# FDA device clearances in Washington: 107 since Nov 2024

Updated October 29, 2026.

FDA made 107 device decisions for applicants in Washington from November 15, 2024 to October 29, 2026: 61 510(k) clearances and De Novo grants and 46 PMA approvals and supplements, for 32 applicants. The newest, P160026/S076 on October 29, 2026, is LIFEPAK® 35 monitor/defibrillator from Physio-Control, Inc..

## The full list

FDA device clearances for applicants in Washington: 107 rows for $5.35, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. Columns: Number, Pathway, Device name, Applicant, Applicant address, Contact, Decision, Decision date, Decision type, Date received, Product code, Device type, Device class, Panel, Applicant state, Applicant country, Supplement reason, Read on, Source. The new rows each week by email, about 5 rows a month: $19 a month. Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (contact, pathway, device name, applicant address, date received, device type and 5 more), which open on your screen as soon as the payment clears and come by email. The rows on this page are a sample.

Buy: https://specstream.ai/data/fda-clearances/state/washington

SpecStream is the live web data engine for teams and agents. It reads every new FDA device clearance and approval as openFDA publishes it, and this page is that reading. Ask for the specialties, product codes or states you follow and each new decision arrives in your sheet, CRM, Slack or agent with the applicant and its address.

- Decisions: 107
- 510(k) and De Novo: 61
- PMA: 46
- Latest decision: October 29, 2026

## Newest decisions

The newest 100 of 107, each linked to its FDA record. The full list adds the applicant's address, the 510(k) contact as FDA prints it, the device class and the date received.

| Decision date | Number | Device | Applicant | Location | Decision | Type | Product code | Source |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| October 29, 2026 | P160026/S076 | LIFEPAK® 35 monitor/defibrillator | Physio-Control, Inc. | Washington | 30-day notice accepted | PMA 30-day notice | MKJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160026S076) |
| October 1, 2026 | K260029 | Firstar Dental Handpieces | FDC Technology Industry Co. | Washington | Substantially Equivalent | 510(k) traditional | EFB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260029) |
| October 1, 2026 | K260027 | Firstar Dental Electric Motor | FDC Technology Industry Co. | Washington | Substantially Equivalent | 510(k) traditional | EBW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260027) |
| September 28, 2026 | P200037/S021 | ASSURE Wearable Cardioverter Defibrillator (WCD) System | Kestra Medical Technologies, Inc. | Washington | 30-day notice accepted | PMA 30-day notice | MVK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200037S021) |
| September 25, 2026 | K262548 | EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | Washington | Substantially Equivalent | 510(k) traditional | IYN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262548) |
| September 24, 2026 | P160026/S074 | LIFEPAK 1000 DEFIBRILLATOR, LIFEPAK 20 DEFIBRILLATOR/ MONITOR, LIFEPAK 20E DEFIBRILLATOR/ MONITOR, LIFEPAK 15... | Physio-Control, Inc. | Washington | 30-day notice accepted | PMA 30-day notice | MKJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160026S074) |
| September 10, 2026 | P160026/S073 | LIFEPAK® 15 monitor/defibrillator | Physio-Control, Inc. | Washington | 30-day notice accepted | PMA 30-day notice | MKJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160026S073) |
| September 10, 2026 | K261696 | ACUNAV Luxera 4D ICE Catheter | Siemens Medical Solutions USA, Inc. | Washington | Substantially Equivalent | 510(k) special | OBJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261696) |
| September 2, 2026 | P160026/S069 | LIFEPAK® 35 monitor/defibrillator | Physio-Control, Inc. | Washington | Approved | PMA real-time process supplement | MKJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160026S069) |
| August 28, 2026 | P160026/S072 | Physio-Control LIFEPAK®35 monitor/defibrillator | Physio-Control, Inc. | Washington | 30-day notice accepted | PMA 30-day notice | MKJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160026S072) |
| August 20, 2026 | P180007/S016 | Spiration® Valve System | Gyrus Acmi, Inc. | Washington | Approved | PMA 180-day supplement | NJK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P180007S016) |
| August 6, 2026 | P160026/S071 | LIFEPAK® 35 monitor/defibrillator | Physio-Control, Inc. | Washington | Approved | PMA real-time process supplement | MKJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160026S071) |
| August 4, 2026 | K262311 | Alturion Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | Washington | Substantially Equivalent | 510(k) special | IYN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262311) |
| July 30, 2026 | P170018/S025 | LIFEPAK® CR2 Defibrillator | Physio-Control, Inc. | Washington | 30-day notice accepted | PMA 30-day notice | MKJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170018S025) |
| July 30, 2026 | P160026/S070 | LIFEPAK 1000 DEFIBRILLATOR, LIFEPAK 20 DEFIBRILLATOR/ MONITOR, LIFEPAK 20E DEFIBRILLATOR/ MONITOR, LIFEPAK 15... | Physio-Control, Inc. | Washington | 30-day notice accepted | PMA 30-day notice | MKJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160026S070) |
| July 27, 2026 | K261211 | Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | Washington | Substantially Equivalent | 510(k) traditional | IYN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261211) |
| July 16, 2026 | P200037/S020 | ASSURE Wearable Cardioverter Defibrillator system (ASSURE system) | Kestra Medical Technologies, Inc. | Washington | 30-day notice accepted | PMA 30-day notice | MVK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200037S020) |
| June 29, 2026 | K260667 | Alturion Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | Washington | Substantially Equivalent | 510(k) traditional | IYN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260667) |
| June 26, 2026 | K261442 | Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array | Cadwell Industries, Inc. | Washington | Substantially Equivalent | 510(k) abbreviated | GXY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261442) |
| June 25, 2026 | P160026/S068 | LIFEPAK® 15 monitor/defibrillator | Physio-Control, Inc. | Washington | 30-day notice accepted | PMA 30-day notice | MKJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160026S068) |
| June 16, 2026 | K260844 | ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin... | Siemens Medical Solutions USA, Inc. | Washington | Substantially Equivalent | 510(k) traditional | IYN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260844) |
| May 27, 2026 | K260680 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | Philips Ultrasound, LLC | Washington | Substantially Equivalent | 510(k) special | IYN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260680) |
| May 27, 2026 | K260123 | EPIQ Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | Washington | Substantially Equivalent | 510(k) traditional | IYN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260123) |
| May 21, 2026 | P180028/S019 | HeartStart FRx Defibrillator (861304) | Philips Medical Systems | Washington | Approved | PMA real-time process supplement | MKJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P180028S019) |
| May 21, 2026 | P160028/S007 | HeartStart FR3 Text (861388) Defibrillator; HeartStart FR3 ECG (861389) Defibrillator | Philips Medical Systems, Inc. | Washington | Approved | PMA real-time process supplement | MKJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160028S007) |
| May 7, 2026 | P180007/S015 | Spiration Valve System (SVS) | Gyrus Acmi, Inc. | Washington | 30-day notice accepted | PMA 30-day notice | NJK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P180007S015) |
| May 6, 2026 | P160026/S067 | LIFEPAK® 15 monitor/defibrillator | Physio-Control, Inc. | Washington | Approved | PMA real-time process supplement | MKJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160026S067) |
| May 5, 2026 | K252558 | Lumify Diagnostic Ultrasound System | Philips Ultrasound, LLC | Washington | Substantially Equivalent | 510(k) traditional | IYN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252558) |
| April 14, 2026 | P200037/S019 | ASSURE Wearable Cardioverter Defibrillator (WCD) System | Kestra Medical Technologies, Inc. | Washington | 30-day notice accepted | PMA 30-day notice | MVK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200037S019) |
| March 27, 2026 | K253595 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | Washington | Substantially Equivalent | 510(k) traditional | IYN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253595) |
| March 10, 2026 | K260595 | Sonosite iLOOK Ultrasound System | FUJIFILM Sonosite, Inc. | Washington | Substantially Equivalent | 510(k) traditional | IYN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260595) |
| March 6, 2026 | P200037/S018 | ASSURE Wearable Cardioverter Defibrillator (WCD) System | Kestra Medical Technologies, Inc. | Washington | Approved | PMA 180-day supplement | MVK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200037S018) |
| March 5, 2026 | P160026/S066 | LIFEPAK 35 monitor/defibrillator | Physio-Control, Inc. | Washington | 30-day notice accepted | PMA 30-day notice | MKJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160026S066) |
| February 23, 2026 | P160026/S065 | LIFEPAK® 35 monitor/defibrillator | Physio-Control, Inc. | Washington | Approved | PMA real-time process supplement | MKJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160026S065) |
| February 13, 2026 | K250233 | PreemptiveAI Clinical SDK | Measure Labs, Inc. (Dba Preemptiveai, Inc.) | Washington | Substantially Equivalent | 510(k) traditional | DXH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250233) |
| February 2, 2026 | P180028/S018 | HeartStart FRx Defibrillator | Philips Medical Systems | Washington | 30-day notice accepted | PMA 30-day notice | MKJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P180028S018) |
| February 2, 2026 | P160029/S029 | HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A) | Philips Medical Systems, Inc. | Washington | 30-day notice accepted | PMA 30-day notice | NSA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160029S029) |
| January 30, 2026 | K251769 | RevealAI-Lung | Precision Medical Ventures, Inc. Dba Revealdx | Washington | Substantially Equivalent | 510(k) traditional | POK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251769) |
| January 16, 2026 | K252960 | SOLIUS PRO UVB Light Panel | Solius Labs, Inc. | Washington | Substantially Equivalent | 510(k) traditional | SGZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252960) |
| January 7, 2026 | K252507 | SmileInspector | Amv Consulting, LLC | Washington | Substantially Equivalent | 510(k) traditional | PNN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252507) |
| December 22, 2025 | K252557 | Lumify Diagnostic Ultrasound System | Philips Ultrasound, LLC | Washington | Substantially Equivalent | 510(k) traditional | IYN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252557) |
| December 15, 2025 | K252950 | Paradigm System | Proprio, Inc. | Washington | Substantially Equivalent | 510(k) traditional | OLO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252950) |
| December 14, 2025 | K250851 | Hypnos (369054-200) | Cadwell Industries, Inc. | Washington | Substantially Equivalent | 510(k) traditional | OLZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250851) |
| December 10, 2025 | K251598 | Intellidrop | Brainspace, Inc. | Washington | Substantially Equivalent | 510(k) traditional | JXG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251598) |
| December 4, 2025 | P160026/S063 | LIFEPAK® 35 Defibrillator/monitor | Physio-Control, Inc. | Washington | 30-day notice accepted | PMA 30-day notice | MKJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160026S063) |
| November 21, 2025 | P160026/S064 | LIFEPAK® 35 monitor/defibrillator | Physio-Control, Inc. | Washington | 30-day notice accepted | PMA 30-day notice | MKJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160026S064) |
| November 17, 2025 | K253487 | ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | Washington | Substantially Equivalent | 510(k) traditional | IYN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253487) |
| November 13, 2025 | K253457 | ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | Washington | Substantially Equivalent | 510(k) traditional | IYN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253457) |
| November 6, 2025 | P170018/S023 | LIFEPAK® CR2 Automated External Defibrillator | Physio-Control, Inc. | Washington | Approved | PMA real-time process supplement | MKJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170018S023) |
| November 3, 2025 | K253448 | Sonosite MT Ultrasound System | FUJIFILM Sonosite, Inc. | Washington | Substantially Equivalent | 510(k) traditional | IYN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253448) |
| October 14, 2025 | P160026/S062 | LIFEPAK 1000 defibrillator | Physio-Control, Inc. | Washington | 30-day notice accepted | PMA 30-day notice | MKJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160026S062) |
| October 14, 2025 | K253099 | LIFEPAK 15 AC Power Adapter (41577-000333) | Physio-Control, Inc. | Washington | Substantially Equivalent | 510(k) special | MPD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253099) |
| October 12, 2025 | K251595 | COVID-19 Detect Rapid Self -Test | InBios International, Inc. | Washington | Substantially Equivalent | 510(k) traditional | QYT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251595) |
| October 9, 2025 | K251651 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | Washington | Substantially Equivalent | 510(k) special | IYN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251651) |
| September 29, 2025 | P170018/S024 | LIFEPACK® CR2 Automated External Defibrillator (AED) | Physio-Control, Inc. | Washington | 30-day notice accepted | PMA 30-day notice | MKJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170018S024) |
| September 25, 2025 | K251812 | Steripath® Flow™ Blood Collection System | Magnolia Medical Technologies | Washington | Substantially Equivalent | 510(k) traditional | JKA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251812) |
| September 22, 2025 | K251743 | SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System | Surgical Principals, Inc. | Washington | Substantially Equivalent | 510(k) traditional | GCJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251743) |
| September 18, 2025 | K251597 | InnerView System | Perimetrics, Inc. | Washington | Substantially Equivalent | 510(k) traditional | EKX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251597) |
| September 5, 2025 | P180028/S017 | HeartStart FRx Defibrillator and HeartStart SMART Pads II | Philips Medical Systems | Washington | 30-day notice accepted | PMA 30-day notice | MKJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P180028S017) |
| August 29, 2025 | K252019 | CurvaFix Low Profile System | Curvafix, Inc. | Washington | Substantially Equivalent | 510(k) traditional | HWC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252019) |
| August 29, 2025 | K251106 | Sonosite LX and Sonosite PX Ultrasound Systems | FUJIFILM Sonosite, Inc. | Washington | Substantially Equivalent | 510(k) traditional | IYN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251106) |
| August 20, 2025 | K251481 | ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON... | Siemens Medical Solutions USA, Inc. | Washington | Substantially Equivalent | 510(k) traditional | IYN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251481) |
| July 24, 2025 | K251455 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | Washington | Substantially Equivalent | 510(k) special | IYN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251455) |
| July 22, 2025 | P200037/S017 | ASSURE Wearable Cardioverter Defibrillator (WCD) System | Kestra Medical Technologies, Inc. | Washington | 30-day notice accepted | PMA 30-day notice | MVK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200037S017) |
| July 18, 2025 | K252218 | MF SC GEN2 Facial Toning System | Micro Current Technology, Inc. | Washington | Substantially Equivalent | 510(k) special | NFO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252218) |
| July 10, 2025 | K251830 | Sonosite LX Ultrasound System | FUJIFILM Sonosite, Inc. | Washington | Substantially Equivalent | 510(k) traditional | IYN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251830) |
| June 30, 2025 | P160026/S061 | LIFEPAK FLEX™ Lithium-ion Battery | Physio-Control, Inc. | Washington | 30-day notice accepted | PMA 30-day notice | MKJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160026S061) |
| June 20, 2025 | P170018/S022 | LIFEPAK® CR2 Defibrillator | Physio-Control, Inc. | Washington | 30-day notice accepted | PMA 30-day notice | MKJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170018S022) |
| June 20, 2025 | P160029/S028 | HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A) | Philips Medical Systems, Inc. | Washington | 30-day notice accepted | PMA 30-day notice | NSA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160029S028) |
| June 20, 2025 | P160026/S060 | LIFEPAK 15 monitor/defibrillator; LIFEPAK 35 monitor/defibrillator; LIFEPAK 20e defibrillator/monitor... | Physio-Control, Inc. | Washington | 30-day notice accepted | PMA 30-day notice | MKJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160026S060) |
| June 20, 2025 | P160026/S059 | LIFEPAK 35 monitor/defibrillator | Physio-Control, Inc. | Washington | 30-day notice accepted | PMA 30-day notice | MKJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160026S059) |
| June 18, 2025 | K250886 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | Philips Ultrasound, LLC | Washington | Substantially Equivalent | 510(k) special | IYN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250886) |
| June 9, 2025 | P180028/S016 | HeartStart FRx Defibrillator (861304) | Philips Medical Systems | Washington | 30-day notice accepted | PMA 30-day notice | MKJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P180028S016) |
| June 9, 2025 | P160029/S027 | HeartStart Home Defibrillator (M5068A) and HeartStart Onsite Defibrillator (M5066A) | Philips Medical Systems, Inc. | Washington | 30-day notice accepted | PMA 30-day notice | NSA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160029S027) |
| June 4, 2025 | K250879 | Paradigm System | Proprio, Inc. | Washington | Substantially Equivalent | 510(k) traditional | OLO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250879) |
| May 21, 2025 | K243793 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | Washington | Substantially Equivalent | 510(k) traditional | IYN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243793) |
| May 16, 2025 | K241581 | Hemodialysis Catheter | Haolang Medical USA Corporation | Washington | Unknown | 510(k) traditional | MSD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241581) |
| May 15, 2025 | K242519 | Lumify Diagnostic Ultrasound System | Philips Ultrasound | Washington | Substantially Equivalent | 510(k) traditional | IYN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242519) |
| May 9, 2025 | P180028/S015 | HeartStart FRx Defibrillator | Philips Medical Systems | Washington | Approved | PMA special supplement | MKJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P180028S015) |
| May 9, 2025 | P160028/S006 | HeartStart FR3 Defibrillator | Philips Medical Systems, Inc. | Washington | Approved | PMA special supplement | MKJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160028S006) |
| May 9, 2025 | K251110 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | Philips Ultrasound, LLC | Washington | Substantially Equivalent | 510(k) special | IYN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251110) |
| May 8, 2025 | K242670 | Lumify Diagnostic Ultrasound System | Philips Ultrasound | Washington | Substantially Equivalent | 510(k) traditional | IYN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242670) |
| April 28, 2025 | K250030 | Flash Ultrasound System 5100 Point of Care | Philips Ultrasound, LLC | Washington | Substantially Equivalent | 510(k) traditional | IYN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250030) |
| April 25, 2025 | P200037/S016 | ASSURE Wearable Cardioverter Defibrillator (WCD) System | Kestra Medical Technologies, Inc. | Washington | 30-day notice accepted | PMA 30-day notice | MVK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200037S016) |
| April 25, 2025 | K242321 | Kosmos | EchoNous, Inc. | Washington | Substantially Equivalent | 510(k) traditional | IYN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242321) |
| April 24, 2025 | K233337 | Freespira Breathing System | Freespira, Inc. | Washington | Substantially Equivalent | 510(k) traditional | SEN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K233337) |
| April 18, 2025 | P050048/S010 | MONOLISA ANTI-HBS EIA | Bio-Rad Laboratories | Washington | 30-day notice accepted | PMA 30-day notice | LOM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P050048S010) |
| April 18, 2025 | K242170 | K-ASSAY CRP (Ver.2) | Kamiya Biomedical Company, LLC | Washington | Substantially Equivalent | 510(k) traditional | DCK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242170) |
| April 10, 2025 | K250177 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | Washington | Substantially Equivalent | 510(k) traditional | IYN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250177) |
| April 3, 2025 | P160026/S057 | LIFEPAK 1000 DEFIBRILLATOR, LIFEPAK 20 DEFIBRILLATOR/ MONITOR, LIFEPAK 20E DEFIBRILLATOR/ MONITOR, LIFEPAK 15... | Physio-Control, Inc. | Washington | 30-day notice accepted | PMA 30-day notice | MKJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160026S057) |
| March 20, 2025 | K242958 | Joylux Intimacy Gel (PG3100) | Joylux, Inc. | Washington | Substantially Equivalent | 510(k) traditional | NUC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242958) |
| March 17, 2025 | P160026/S053 | LIFEPAK® 35 monitor/defibrillator | Physio-Control, Inc. | Washington | Approved | PMA real-time process supplement | MKJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160026S053) |
| February 21, 2025 | K243258 | Paradigm System | Proprio, Inc. | Washington | Substantially Equivalent | 510(k) traditional | OLO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243258) |
| February 10, 2025 | K241659 | Ultrasound Workspace (UWS 6.0) | Philips Ultrasound, LLC | Washington | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241659) |
| February 6, 2025 | K243794 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | Washington | Substantially Equivalent | 510(k) traditional | IYN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243794) |
| February 3, 2025 | P160026/S056 | LIFEPAK® 1000 Defibrillator | Physio-Control, Inc. | Washington | 30-day notice accepted | PMA 30-day notice | MKJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160026S056) |
| January 31, 2025 | P160026/S055 | LIFEPAK 1000 DEFIBRILLATOR, LIFEPAK 20 DEFIBRILLATOR/ MONITOR, LIFEPAK 20E DEFIBRILLATOR/ MONITOR, LIFEPAK 15... | Physio-Control, Inc. | Washington | 30-day notice accepted | PMA 30-day notice | MKJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160026S055) |
| January 27, 2025 | P160026/S054 | LIFEPAK® 15 monitor | Physio-Control, Inc. | Washington | 30-day notice accepted | PMA 30-day notice | MKJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160026S054) |
| January 27, 2025 | K231297 | Firstar Dental Unit | Firstar Dental Company | Washington | Substantially Equivalent | 510(k) traditional | EIA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231297) |
| January 23, 2025 | K241819 | CephNinja | Cyncronus, LLC | Washington | Substantially Equivalent | 510(k) traditional | LLZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241819) |

## Applicants with the most decisions

| Applicant | Decisions | Latest |
| --- | --- | --- |
| Physio-Control, Inc. | 27 | October 29, 2026 |
| Philips Ultrasound, LLC | 20 | September 25, 2026 |
| Siemens Medical Solutions USA, Inc. | 7 | September 10, 2026 |
| Kestra Medical Technologies, Inc. | 6 | September 28, 2026 |
| Philips Medical Systems, Inc. | 6 | May 21, 2026 |
| Philips Medical Systems | 5 | May 21, 2026 |
| FUJIFILM Sonosite, Inc. | 4 | March 10, 2026 |
| Cadwell Industries, Inc. | 3 | June 26, 2026 |
| Proprio, Inc. | 3 | December 15, 2025 |
| FDC Technology Industry Co. | 2 | October 1, 2026 |
| Gyrus Acmi, Inc. | 2 | August 20, 2026 |
| Philips Ultrasound | 2 | May 15, 2025 |
| Measure Labs, Inc. (Dba Preemptiveai, Inc.) | 1 | February 13, 2026 |
| Precision Medical Ventures, Inc. Dba Revealdx | 1 | January 30, 2026 |
| Solius Labs, Inc. | 1 | January 16, 2026 |
| Amv Consulting, LLC | 1 | January 7, 2026 |
| Brainspace, Inc. | 1 | December 10, 2025 |
| InBios International, Inc. | 1 | October 12, 2025 |
| Magnolia Medical Technologies | 1 | September 25, 2025 |
| Surgical Principals, Inc. | 1 | September 22, 2025 |

## By panel

| Panel | Decisions | Latest |
| --- | --- | --- |
| [Cardiovascular](https://specstream.ai/data/fda-clearances/panel/cardiovascular) | 47 | October 29, 2026 |
| [Radiology](https://specstream.ai/data/fda-clearances/panel/radiology) | 35 | September 25, 2026 |
| [Neurology](https://specstream.ai/data/fda-clearances/panel/neurology) | 8 | June 26, 2026 |
| [Dental](https://specstream.ai/data/fda-clearances/panel/dental) | 5 | October 1, 2026 |
| [Anesthesiology](https://specstream.ai/data/fda-clearances/panel/anesthesiology) | 3 | August 20, 2026 |
| [Microbiology](https://specstream.ai/data/fda-clearances/panel/microbiology) | 2 | October 12, 2025 |
| [Gastroenterology, Urology](https://specstream.ai/data/fda-clearances/panel/gastroenterology-urology) | 2 | September 22, 2025 |
| [General, Plastic Surgery](https://specstream.ai/data/fda-clearances/panel/general-plastic-surgery) | 1 | January 16, 2026 |
| [Clinical Chemistry](https://specstream.ai/data/fda-clearances/panel/clinical-chemistry) | 1 | September 25, 2025 |
| [Orthopedic](https://specstream.ai/data/fda-clearances/panel/orthopedic) | 1 | August 29, 2025 |
| [Immunology](https://specstream.ai/data/fda-clearances/panel/immunology) | 1 | April 18, 2025 |
| [Obstetrics/Gynecology](https://specstream.ai/data/fda-clearances/panel/obstetrics-gynecology) | 1 | March 20, 2025 |

## By decision type

| Decision type | Decisions | Latest |
| --- | --- | --- |
| [510(k) traditional](https://specstream.ai/data/fda-clearances/decision/510k-traditional) | 51 | October 1, 2026 |
| [PMA 30-day notice](https://specstream.ai/data/fda-clearances/decision/pma-30-day-notice) | 33 | October 29, 2026 |
| [510(k) special](https://specstream.ai/data/fda-clearances/decision/510k-special) | 9 | September 10, 2026 |
| [PMA real-time process supplement](https://specstream.ai/data/fda-clearances/decision/pma-real-time-process-supplement) | 9 | September 2, 2026 |
| [PMA 180-day supplement](https://specstream.ai/data/fda-clearances/decision/pma-180-day-supplement) | 2 | August 20, 2026 |
| [PMA special supplement](https://specstream.ai/data/fda-clearances/decision/pma-special-supplement) | 2 | May 9, 2025 |
| [510(k) abbreviated](https://specstream.ai/data/fda-clearances/decision/510k-abbreviated) | 1 | June 26, 2026 |

## Where FDA publishes these decisions

- [FDA 510(k) database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm)
- [FDA PMA database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm)
- [openFDA device API](https://open.fda.gov/apis/device/)

Source: [openFDA device 510(k) and PMA (U.S. Food and Drug Administration)](https://open.fda.gov/apis/device/). CC0 1.0 (openFDA). Decisions are as FDA publishes them in its 510(k) and PMA databases, read through openFDA. A PMA row is the original approval or one supplement. The panel is the FDA advisory committee that reviewed the device. FDA adds decisions to openFDA some weeks after their date, so the newest weeks fill in later. The 510(k) contact is in the full list only, as FDA prints it for the submission.

Free to reuse with credit to SpecStream under [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/).