# FDA Anesthesiology device clearances: 279 since Nov 2024

Updated October 30, 2026.

FDA made 279 device decisions in anesthesiology (FDA review panel) from November 12, 2024 to October 30, 2026: 205 510(k) clearances and De Novo grants and 74 PMA approvals and supplements, for 168 applicants. The newest, K253095 on October 30, 2026, is ULSPIRA TS™ Nitric Oxide Therapy System from Airgas Therapeutics, LLC.

## The full list

FDA anesthesiology device clearances and approvals: 279 rows for $13.95, 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 11 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 6 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/panel/anesthesiology

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: 279
- 510(k) and De Novo: 205
- PMA: 74
- Latest decision: October 30, 2026

## Newest decisions

The newest 100 of 279, 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 30, 2026 | K253095 | ULSPIRA TS™ Nitric Oxide Therapy System | Airgas Therapeutics, LLC | Pennsylvania | Substantially Equivalent | 510(k) traditional | MRN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253095) |
| October 26, 2026 | P230042/S010 | Optune Lua | Novocure, GmbH |  | 30-day notice accepted | PMA 30-day notice | SDA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230042S010) |
| October 26, 2026 | P130008/S144 | INSPIRE II UPPER AIRWAY STIMULATOR | Inspire Medical Systems | Minnesota | Approved | PMA real-time process supplement | MNQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130008S144) |
| October 26, 2026 | K260671 | RP Check (RP01) | MD Diagnostics, Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | CAP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260671) |
| October 23, 2026 | K260251 | BreathCare PAP III (YH-390N) | Suzhou Yuyue Medical Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | BZD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260251) |
| October 22, 2026 | P130008/S147 | Model 3150 IPG | Inspire Medical Systems | Minnesota | 30-day notice accepted | PMA 30-day notice | MNQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130008S147) |
| October 16, 2026 | K263254 | Disposable Manual Resuscitator (NPVC-001/RTMA;NPVC-002/RTMA;NPVC-003/RTMA1) | Xiamen Compower Medical Tech. Co., Ltd. | China | Substantially Equivalent | 510(k) special | BTM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263254) |
| October 13, 2026 | P130008/S146 | Model 3150 IPG | Inspire Medical Systems | Minnesota | 30-day notice accepted | PMA 30-day notice | MNQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130008S146) |
| October 11, 2026 | K253717 | Helo™ Return | Endovascular Engineering, Inc. | California | Substantially Equivalent | 510(k) traditional | SHJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253717) |
| October 5, 2026 | K261939 | Glucommander | Glytec, LLC | South Carolina | Substantially Equivalent | 510(k) traditional | NDC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261939) |
| September 28, 2026 | P850064/S056 | LifePulse® High Frequency Ventilator | Bunnell, Inc. | Utah | Approved | PMA 180-day supplement | LSZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P850064S056) |
| September 25, 2026 | P240012/S008 | AeroPace® System | Lungpacer Medical USA, Inc. | Pennsylvania | Approved | PMA real-time process supplement | SDL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240012S008) |
| September 25, 2026 | K261372 | Profoject™ LOR Syringe | CMT Health PTE., Ltd. | Singapore | Substantially Equivalent | 510(k) traditional | CAZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261372) |
| September 25, 2026 | K261262 | Altis Full Face Mask | Respironics, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | BZD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261262) |
| September 25, 2026 | K260140 | Aevice Wheeze Detection Module | Aevice Health Pte. , Ltd. | Singapore | Substantially Equivalent | 510(k) traditional | PHZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260140) |
| September 24, 2026 | K260949 | Disposable Belts for Polysomnography (CNSAC) | CNSAC Medshop GmbH | Germany | Substantially Equivalent | 510(k) traditional | MNR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260949) |
| September 23, 2026 | K254289 | Portable Oxygen Concentrator (OX-1A-E, OX-1B) | Oxytek Medical Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | CAW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254289) |
| September 18, 2026 | K254171 | Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) | Shenzhen Mericonn Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | CAF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254171) |
| September 16, 2026 | K260226 | ElintMAX Respiratory Monitor (ElintMAX Monitor A1) | Amptron Medical, Inc. | California | Substantially Equivalent | 510(k) traditional | BZK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260226) |
| September 11, 2026 | P180002/S032 | Zephyr Endobronchial Valve System | Pulmonx Corporation | California | Approved | PMA real-time process supplement | NJK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P180002S032) |
| September 11, 2026 | K253063 | Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach... | Vitaltec Corporation | Taiwan | Substantially Equivalent | 510(k) special | BTO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253063) |
| September 3, 2026 | K251794 | Tenax® Laser Resistant Endotracheal Tube | Bryan Medical, Inc. | Ohio | Substantially Equivalent | 510(k) traditional | BTR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251794) |
| August 28, 2026 | P130008/S136 | Model 4063 Inspire Stimulation Lead | Inspire Medical Systems | Minnesota | Approved | PMA 135-day supplement | MNQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130008S136) |
| August 28, 2026 | P130008/S123 | INSPIRE II UPPER AIRWAY STIMULATOR | Inspire Medical Systems | Minnesota | Approved | PMA 135-day supplement | MNQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130008S123) |
| August 27, 2026 | K262268 | Optiflow Oxygen Kit (AA484J) | Fisher and Paykel Healthcare Limited | New Zealand | Substantially Equivalent | 510(k) special | BTT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262268) |
| August 27, 2026 | K261360 | EasyCare Tx 2 | Resmed Corp | California | Substantially Equivalent | 510(k) traditional | MOD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261360) |
| August 24, 2026 | K260604 | BiWaze Clear System | Abmrc, LLC | Minnesota | Substantially Equivalent | 510(k) traditional | NHJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260604) |
| 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 20, 2026 | K260242 | CPETWise Platform | Medibyt , Ltd. | Israel | Substantially Equivalent | 510(k) traditional | BTY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260242) |
| August 20, 2026 | K253807 | Valence InVent Xtend™ (CVG-4101-VXA) | Convergence Medical Sciences , Ltd. | Canada | Substantially Equivalent | 510(k) traditional | MOD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253807) |
| August 17, 2026 | P130008/S143 | Inspire Upper Airway Stimulation (UAS) System | Inspire Medical Systems | Minnesota | 30-day notice accepted | PMA 30-day notice | MNQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130008S143) |
| August 14, 2026 | K260171 | Portable Oxygen Concentrator (PO1 5B, PO1 6B) | BMC Medical Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | CAW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260171) |
| August 13, 2026 | K261499 | TrachFlush | Aw Technologies Aps | Denmark | Substantially Equivalent | 510(k) traditional | BSK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261499) |
| August 12, 2026 | K251641 | GF-310R Multigas Unit (GF-310R) | Nihon Kohden Corporation | Japan | Substantially Equivalent | 510(k) traditional | CCK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251641) |
| August 11, 2026 | P130008/S142 | Model 4063 Inspire Stimulation Lead | Inspire Medical Systems | Minnesota | 30-day notice accepted | PMA 30-day notice | MNQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130008S142) |
| July 31, 2026 | K254042 | WatchPAT SW | Itamar Medical , Ltd. | Israel | Substantially Equivalent | 510(k) traditional | MNR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254042) |
| July 30, 2026 | P240024/S004 | Genio® System 2.1 | Nyxoah S.A. |  | Approved | PMA real-time process supplement | MNQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240024S004) |
| July 30, 2026 | K261389 | PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1) | Salter Labs | Texas | Substantially Equivalent | 510(k) traditional | CCL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261389) |
| July 23, 2026 | K253044 | RXiBreeze PAP System (RXiBreeze 20C) | Resvent Medical Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | BZD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253044) |
| July 20, 2026 | K261011 | Sleep Apnea Feature (v2.0) | Samsung Electronics Co., Ltd. | South Korea | Substantially Equivalent | 510(k) traditional | QZW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261011) |
| July 15, 2026 | K260050 | WRAP System | Huneo, LLC | Ohio | Substantially Equivalent | 510(k) traditional | MNR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260050) |
| July 14, 2026 | K261633 | VisuBreath | Affirm Medical Technologies II, LLC | California | Substantially Equivalent | 510(k) traditional | CCK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261633) |
| July 10, 2026 | P130008/S140 | Model 3150 Implantable Pulse Generator (IPG) | Inspire Medical Systems | Minnesota | Approved | PMA 135-day supplement | MNQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130008S140) |
| July 1, 2026 | P230042/S008 | Optune Lua® | Novocure, GmbH |  | Approved | PMA real-time process supplement | SDA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230042S008) |
| June 25, 2026 | K253330 | A5 Anesthesia System (A5); A7 Anesthesia System (A7) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | BSZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253330) |
| June 25, 2026 | K253274 | BedDot (G1) | Intelligent Dots, LLC | Georgia | Substantially Equivalent | 510(k) traditional | BZQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253274) |
| June 23, 2026 | K253180 | Microlife Digital Peak Flow Meter, Model PF200B (PF200B) | Microlife Corporation | Taiwan | Substantially Equivalent | 510(k) traditional | BZH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253180) |
| June 22, 2026 | P240012/S007 | AeroPace® System | Lungpacer Medical USA, Inc. | Pennsylvania | Approved | PMA 180-day supplement | SDL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240012S007) |
| June 22, 2026 | P240012/S006 | AeroPace® System | Lungpacer Medical USA, Inc. | Pennsylvania | Approved | PMA real-time process supplement | SDL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240012S006) |
| June 22, 2026 | K253148 | RX-1 Sleep | Vivaquant, Inc. Dba Rhythm Express | Minnesota | Substantially Equivalent | 510(k) traditional | MNR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253148) |
| June 18, 2026 | P250013/S002 | aura6000™ system | LivaNova USA, Inc. | Texas | Approved | PMA 180-day supplement | MNQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250013S002) |
| June 18, 2026 | K252066 | inspired™ Heated Breathing Circuit (510-008); inspired™ Heated Breathing Circuit (510-009); inspired™... | Vincent Healthcare Products Limited | Hong Kong | Substantially Equivalent | 510(k) traditional | BZE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252066) |
| June 18, 2026 | DEN250025 | Syncron-E | Autonomous Healthcare, Inc. | California | Unknown | De Novo | QVC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN250025) |
| June 17, 2026 | P180002/S031 | Zephyr Endobronchial Valve (EBV) System | Pulmonx Corporation | California | 30-day notice accepted | PMA 30-day notice | NJK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P180002S031) |
| June 17, 2026 | K252399 | Portable Oxygen Concentrator | Honsun (Nantong) Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | CAW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252399) |
| June 16, 2026 | K253001 | KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5) | Hunan Ruijiong Biotech Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | NHJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253001) |
| June 12, 2026 | K253437 | Spiro-VISTA | Spiro Robotics | California | Substantially Equivalent | 510(k) traditional | BTR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253437) |
| June 11, 2026 | K251326 | Respiration Rate algorithm | Edwards Lifesciences, LLC | California | Substantially Equivalent | 510(k) traditional | BZQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251326) |
| June 8, 2026 | P240024/S003 | Genio® System 2.1 | Nyxoah S.A. |  | Approved | PMA real-time process supplement | MNQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240024S003) |
| June 4, 2026 | K253553 | Orion | Resmed Corp | California | Substantially Equivalent | 510(k) traditional | BZD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253553) |
| June 2, 2026 | K260270 | FindAir ONE for pMDI (FAO-MDI-V12-GRE-001) | FindAir Sp. z o.o. | Poland | Substantially Equivalent | 510(k) traditional | CAF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260270) |
| June 2, 2026 | K252844 | Tyto Insights for Wheeze Detection (with PCCP) | Tyto Care , Ltd. | Israel | Substantially Equivalent | 510(k) traditional | PHZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252844) |
| May 29, 2026 | K253119 | CoSense ETCO Monitor | Capnia, Inc. | California | Substantially Equivalent | 510(k) traditional | CCJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253119) |
| May 29, 2026 | K252965 | Oxygen Concentrator (OX-5A, OX-5C) | Oxytek Medical Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | CAW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252965) |
| May 29, 2026 | K252802 | Peak Flow Meter (PF-10(BR-PEF231)) | Shenzhen Bi-Rich Medical Devices Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | BZH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252802) |
| May 28, 2026 | P130008/S139 | Inspire Model 4063 Leads; Inspire Model 4340 Leads | Inspire Medical Systems | Minnesota | 30-day notice accepted | PMA 30-day notice | MNQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130008S139) |
| May 27, 2026 | K254104 | ResScan Essentials | Resmed Corp | California | Substantially Equivalent | 510(k) traditional | BZD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254104) |
| May 27, 2026 | K254102 | Glucommander | Glytec, LLC | South Carolina | Substantially Equivalent | 510(k) traditional | NDC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254102) |
| May 22, 2026 | K261098 | TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric... | Senzime AB | Sweden | Substantially Equivalent | 510(k) special | KOI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261098) |
| May 21, 2026 | K252746 | Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL) | Drägerwerk AG Co. Kgaa | Germany | Substantially Equivalent | 510(k) traditional | BSZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252746) |
| May 21, 2026 | K251920 | Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask | Dcstar, Inc. | New York | Substantially Equivalent | 510(k) traditional | BZD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251920) |
| May 15, 2026 | K252643 | Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled | Teleflex Medical Sdn. Bhd. | Malaysia | Substantially Equivalent | 510(k) traditional | CAH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252643) |
| May 12, 2026 | K260051 | CorVision® (91-205-Z0014) | CorVent® Medical, Inc. | North Dakota | Substantially Equivalent | 510(k) traditional | MOD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260051) |
| May 7, 2026 | P850064/S058 | LifePulse High Frequency Ventilator (LifePulse HFV) Model 204 | Bunnell, Inc. | Utah | 30-day notice accepted | PMA 30-day notice | LSZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P850064S058) |
| 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 7, 2026 | K253647 | Evita (V800); Evita (V600) | Draegerwerk AG & CO Kgaa | Germany | Substantially Equivalent | 510(k) traditional | CBK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253647) |
| May 1, 2026 | K260910 | EndoTool IV Cloud 1.0 | Glooko, Inc. | California | Substantially Equivalent | 510(k) traditional | NDC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260910) |
| May 1, 2026 | K253030 | Capnostream™35 Portable Respiratory Monitor (PM35MN) | Covidien, LLC | Colorado | Substantially Equivalent | 510(k) traditional | CCK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253030) |
| April 30, 2026 | P250013/S001 | aura6000™ system | LivaNova USA, Inc. | Texas | Approved | PMA 180-day supplement | MNQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250013S001) |
| April 30, 2026 | K252849 | AffloVest® Mobile Airway Clearance Therapy | Tactile Medical | Minnesota | Substantially Equivalent | 510(k) traditional | BYI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252849) |
| April 30, 2026 | K251583 | Ambu® Virobac II® Exhalation Filter | Ambu A/S | Denmark | Substantially Equivalent | 510(k) traditional | CAH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251583) |
| April 29, 2026 | K253166 | F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) | BMC Medical Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | BZD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253166) |
| April 27, 2026 | K252628 | CASSIE | Wesper, Inc. | New York | Substantially Equivalent | 510(k) traditional | MNR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252628) |
| April 23, 2026 | K252407 | OxyGo Portable Oxygen Concentrator (1400-7000) | Mv Life, LLC | Florida | Substantially Equivalent | 510(k) traditional | CAW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252407) |
| April 17, 2026 | K252338 | MySleepDash | Somnetics International, Inc. (Dba Transcend Inc) | Minnesota | Substantially Equivalent | 510(k) traditional | BZD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252338) |
| April 16, 2026 | P130008/S138 | Inspire V Printed Circuit Board Assembly (PCBA) Test System SW | Inspire Medical Systems | Minnesota | 30-day notice accepted | PMA 30-day notice | MNQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130008S138) |
| April 14, 2026 | K252663 | Inbentus Versatile | Iconic Solutions by Murcia, SL | Spain | Substantially Equivalent | 510(k) traditional | CBK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252663) |
| April 13, 2026 | K254078 | HVT 2.0 | Vapotherm, Inc. | New Hampshire | Substantially Equivalent | 510(k) traditional | BTT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254078) |
| April 8, 2026 | K251889 | myAir | Resmed Corp | California | Substantially Equivalent | 510(k) traditional | MNS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251889) |
| April 6, 2026 | K252182 | SV70 Ventilator (SV70) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | MNT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252182) |
| March 26, 2026 | K253549 | DeVilbiss 5 Liter Oxygen Concentrator (555) | Devilbiss Healthcare, LLC | Pennsylvania | Substantially Equivalent | 510(k) traditional | CAW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253549) |
| March 25, 2026 | K253322 | Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78” Infant Circuit, HUD99060KIT /... | Medline Industries, LP | Illinois | Substantially Equivalent | 510(k) traditional | BZE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253322) |
| March 20, 2026 | K251950 | Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107); Endobronchial Blocker Tube... | Hangzhou Tappa Medical Technology Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | CBI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251950) |
| March 18, 2026 | P250013 | aura6000™ system | LivaNova USA, Inc. | Texas | Approved | PMA original approval | MNQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250013) |
| March 17, 2026 | P180002/S030 | Zephyr Endobronchial Valve (EBV) System | Pulmonx Corporation | California | 30-day notice accepted | PMA 30-day notice | NJK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P180002S030) |
| March 17, 2026 | K252078 | BreathePal Bilevel (GFM50-MD2201) | Compal Electronics, Inc. | Taiwan | Substantially Equivalent | 510(k) traditional | MNS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252078) |
| March 13, 2026 | P200044/S013 | LungFit PH | Beyond Air, Inc. | New York | 30-day notice accepted | PMA 30-day notice | QTB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200044S013) |
| March 13, 2026 | P130008/S137 | Model 3150 Implantable Pulse Generator (IPG) | Inspire Medical Systems | Minnesota | 30-day notice accepted | PMA 30-day notice | MNQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130008S137) |
| March 12, 2026 | P010047/S073 | PROGEL™ Pleural Air Leak Sealant | Neomend, Inc. | California | 30-day notice accepted | PMA 30-day notice | NBE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010047S073) |
| March 12, 2026 | K251888 | VPAP Pediatric Face Mask | Hsiner Co., Ltd. | Taiwan | Substantially Equivalent | 510(k) traditional | CBK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251888) |

## Applicants with the most decisions

| Applicant | Decisions | Latest |
| --- | --- | --- |
| Inspire Medical Systems | 30 | October 26, 2026 |
| Lungpacer Medical USA, Inc. | 9 | September 25, 2026 |
| Novocure, GmbH | 7 | October 26, 2026 |
| Resmed Corp | 6 | August 27, 2026 |
| Pulmonx Corporation | 5 | September 11, 2026 |
| Nyxoah S.A. | 5 | July 30, 2026 |
| Covidien, LLC | 5 | May 1, 2026 |
| Fisher & Paykel Healthcare, Ltd. | 5 | December 19, 2025 |
| PAJUNK GmbH Medizintechnologie | 5 | July 1, 2025 |
| Breas Medical AB | 5 | May 20, 2025 |
| Beyond Air, Inc. | 4 | March 13, 2026 |
| Neomend, Inc. | 4 | March 12, 2026 |
| Bunnell, Inc. | 3 | September 28, 2026 |
| BMC Medical Co., Ltd. | 3 | August 14, 2026 |
| Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 3 | June 25, 2026 |
| LivaNova USA, Inc. | 3 | June 18, 2026 |
| Medline Industries, LP | 3 | March 25, 2026 |
| Huxley Medical | 3 | December 10, 2025 |
| ZOLL Medical Corporation | 3 | July 23, 2025 |
| Airgas Therapeutics, LLC | 2 | October 30, 2026 |

## By decision type

| Decision type | Decisions | Latest |
| --- | --- | --- |
| [510(k) traditional](https://specstream.ai/data/fda-clearances/decision/510k-traditional) | 191 | October 30, 2026 |
| [PMA 30-day notice](https://specstream.ai/data/fda-clearances/decision/pma-30-day-notice) | 36 | October 26, 2026 |
| [PMA real-time process supplement](https://specstream.ai/data/fda-clearances/decision/pma-real-time-process-supplement) | 17 | October 26, 2026 |
| [510(k) special](https://specstream.ai/data/fda-clearances/decision/510k-special) | 13 | October 16, 2026 |
| [PMA 180-day supplement](https://specstream.ai/data/fda-clearances/decision/pma-180-day-supplement) | 12 | September 28, 2026 |
| [PMA 135-day supplement](https://specstream.ai/data/fda-clearances/decision/pma-135-day-supplement) | 5 | August 28, 2026 |
| [PMA original approval](https://specstream.ai/data/fda-clearances/decision/pma-original-approval) | 3 | March 18, 2026 |
| [De Novo](https://specstream.ai/data/fda-clearances/decision/de-novo) | 1 | June 18, 2026 |
| [PMA special supplement](https://specstream.ai/data/fda-clearances/decision/pma-special-supplement) | 1 | February 14, 2025 |

## By state or country

| State or country | Decisions | Latest |
| --- | --- | --- |
| [Minnesota](https://specstream.ai/data/fda-clearances/state/minnesota) | 35 | October 26, 2026 |
| [China](https://specstream.ai/data/fda-clearances/country/china) | 35 | October 23, 2026 |
| [California](https://specstream.ai/data/fda-clearances/state/california) | 34 | October 11, 2026 |
| [Pennsylvania](https://specstream.ai/data/fda-clearances/state/pennsylvania) | 16 | October 30, 2026 |
| [Germany](https://specstream.ai/data/fda-clearances/country/germany) | 11 | September 24, 2026 |
| [Taiwan](https://specstream.ai/data/fda-clearances/country/taiwan) | 11 | September 11, 2026 |
| [Israel](https://specstream.ai/data/fda-clearances/country/israel) | 8 | August 20, 2026 |
| New Zealand | 7 | August 27, 2026 |
| [New York](https://specstream.ai/data/fda-clearances/state/new-york) | 7 | May 21, 2026 |
| [Georgia](https://specstream.ai/data/fda-clearances/state/georgia) | 6 | June 25, 2026 |
| [Sweden](https://specstream.ai/data/fda-clearances/country/sweden) | 6 | May 22, 2026 |
| [United Kingdom](https://specstream.ai/data/fda-clearances/country/united-kingdom) | 5 | October 26, 2026 |
| [Texas](https://specstream.ai/data/fda-clearances/state/texas) | 5 | July 30, 2026 |
| [Colorado](https://specstream.ai/data/fda-clearances/state/colorado) | 5 | May 1, 2026 |
| [Massachusetts](https://specstream.ai/data/fda-clearances/state/massachusetts) | 5 | December 19, 2025 |
| [Utah](https://specstream.ai/data/fda-clearances/state/utah) | 4 | September 28, 2026 |
| [Singapore](https://specstream.ai/data/fda-clearances/country/singapore) | 4 | September 25, 2026 |
| [Illinois](https://specstream.ai/data/fda-clearances/state/illinois) | 4 | March 25, 2026 |
| [Australia](https://specstream.ai/data/fda-clearances/country/australia) | 4 | February 23, 2026 |
| [Ohio](https://specstream.ai/data/fda-clearances/state/ohio) | 3 | September 3, 2026 |
| [Washington](https://specstream.ai/data/fda-clearances/state/washington) | 3 | August 20, 2026 |
| [Denmark](https://specstream.ai/data/fda-clearances/country/denmark) | 3 | August 13, 2026 |
| [South Korea](https://specstream.ai/data/fda-clearances/country/south-korea) | 3 | July 20, 2026 |
| [France](https://specstream.ai/data/fda-clearances/country/france) | 3 | August 12, 2025 |
| [North Carolina](https://specstream.ai/data/fda-clearances/state/north-carolina) | 3 | April 29, 2025 |

## 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/).