# FDA device clearances in Utah: 98 since Nov 2024

Updated October 29, 2026.

FDA made 98 device decisions for applicants in Utah from November 27, 2024 to October 29, 2026: 89 510(k) clearances and De Novo grants and 9 PMA approvals and supplements, for 46 applicants. The newest, K263459 on October 29, 2026, is SWICS™ from Bloom Surgical, Inc..

## The full list

FDA device clearances for applicants in Utah: 98 rows for $5, 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.

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

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: 98
- 510(k) and De Novo: 89
- PMA: 9
- Latest decision: October 29, 2026

## Newest decisions

The newest 98 of 98, 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 | K263459 | SWICS™ | Bloom Surgical, Inc. | Utah | Substantially Equivalent | 510(k) traditional | GCJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263459) |
| October 21, 2026 | K262136 | BIOFIRE SPOTFIRE Vaginitis (VG) Panel | Biofire Diagnostics, LLC | Utah | Substantially Equivalent | De Novo (dual track) | PQA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262136) |
| October 9, 2026 | K260156 | TruVision Single-Use 1.9mm Arthroscopy System | Nexus CMF, LLC | Utah | Substantially Equivalent | 510(k) traditional | HRX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260156) |
| October 2, 2026 | K263116 | OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts | OsteoCentric Technologies | Utah | Substantially Equivalent | 510(k) special | HWC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263116) |
| 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 22, 2026 | K263054 | BIOFIRE Respiratory Panel 2.1 (RP2.1) | Biofire Diagnostics | Utah | Substantially Equivalent | 510(k) special | QOF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263054) |
| September 16, 2026 | K254181 | Aristotle 65 Macrowire | Scientia Vascular | Utah | Substantially Equivalent | 510(k) traditional | MOF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254181) |
| September 11, 2026 | K262025 | Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium... | INNO Holdings Inc. DBA Innovasis | Utah | Substantially Equivalent | 510(k) traditional | OVD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262025) |
| September 10, 2026 | K254074 | TruPress | Procerus Enterprises | Utah | Substantially Equivalent | 510(k) traditional | DRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254074) |
| August 6, 2026 | K260223 | Aristotle Mini Guidewire | Scientia Vascular, Inc. | Utah | Substantially Equivalent | 510(k) traditional | MOF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260223) |
| July 29, 2026 | K262240 | SSPC NXT Delivery Catheter | CenterPoint Systems, LLC | Utah | Substantially Equivalent | 510(k) special | DQY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262240) |
| July 29, 2026 | K261766 | CPS Locator 3D Plus Delivery Catheter | CenterPoint Systems, LLC | Utah | Substantially Equivalent | 510(k) special | DQY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261766) |
| July 27, 2026 | K261310 | FlexTract Deflectable-Rotational Dilator Sheath Set | Merit Medical Systems, Inc. | Utah | Substantially Equivalent | 510(k) traditional | DRE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261310) |
| July 23, 2026 | K261734 | Klassic Infection Spacer System | Total Joint Orthopedics, Inc. | Utah | Substantially Equivalent | 510(k) traditional | JWH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261734) |
| July 22, 2026 | K262086 | PreludeSYNC™ Radial Compression Device | Merit Medical Systems, Inc. | Utah | Substantially Equivalent | 510(k) special | DXC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262086) |
| July 17, 2026 | K261475 | BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit | Biofire Defense, LLC | Utah | Substantially Equivalent | 510(k) traditional | PMN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261475) |
| July 16, 2026 | K260002 | Socrates Aspiration System (Socrates 70 Aspiration Catheter) | Scientia Vascular, Inc. | Utah | Substantially Equivalent | 510(k) traditional | NRY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260002) |
| July 1, 2026 | K262228 | Transcend Bulk Fill Flowable Composite | Ultradent Products, Inc. | Utah | Substantially Equivalent | 510(k) traditional | EBF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262228) |
| June 24, 2026 | K251929 | SilverCeuticals® Antimicrobial Wound Gel | Silverceuticals, Inc. | Utah | Substantially Equivalent | 510(k) traditional | FRO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251929) |
| June 22, 2026 | K261950 | Health Line Tearaway Introducer | Health Line International Corporation | Utah | Substantially Equivalent | 510(k) traditional | DYB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261950) |
| June 22, 2026 | K261279 | DeltaNEC Interbody System | Nexus Spine | Utah | Substantially Equivalent | 510(k) traditional | OVE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261279) |
| June 11, 2026 | P240023/S005 | WRAPSODY® Cell-Impermeable Endoprosthesis | Merit Medical Systems, Inc. | Utah | 30-day notice accepted | PMA 30-day notice | PFV | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240023S005) |
| June 5, 2026 | K261492 | FieldFlex Steerable Sheath | CenterPoint Systems, LLC | Utah | Substantially Equivalent | 510(k) special | DYB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261492) |
| May 29, 2026 | K260077 | OrthoGrid Hip AI® 4.0 | OrthoGrid Systems, Inc. | Utah | Substantially Equivalent | 510(k) traditional | QIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260077) |
| May 29, 2026 | K253103 | Nexus DRF Digital X-ray Imaging System | Varex Imaging Corporation | Utah | Substantially Equivalent | 510(k) traditional | JAA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253103) |
| May 13, 2026 | K254073 | StatSeal Disc | Merit Medical Systems, Inc. | Utah | Substantially Equivalent | 510(k) traditional | FRO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254073) |
| 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) |
| April 30, 2026 | K261404 | UltraEZ | Ultradent Products, Inc. | Utah | Substantially Equivalent | 510(k) special | LBH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261404) |
| April 29, 2026 | K253579 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire | Scientia Vascular, Inc. | Utah | Substantially Equivalent | 510(k) traditional | MOF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253579) |
| April 10, 2026 | K252699 | CoAptix S System | University of Utah, Department of Orthopaedics | Utah | Substantially Equivalent | 510(k) traditional | HWC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252699) |
| April 7, 2026 | K260942 | AuST Steerable Sheath | CenterPoint Systems, LLC | Utah | Substantially Equivalent | 510(k) special | DYB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260942) |
| April 2, 2026 | K252137 | BD Insyte™ IV Catheter | Becton Dickinson Infusion Therapy Systems, Inc. | Utah | Substantially Equivalent | 510(k) traditional | FOZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252137) |
| March 27, 2026 | K260697 | VyPlate™ Anterior Cervical Plate System | Vy Spine, LLC | Utah | Substantially Equivalent | 510(k) special | KWQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260697) |
| March 19, 2026 | K253432 | DiversiVy™ Facet Screw System | Vy Spine, LLC | Utah | Substantially Equivalent | 510(k) traditional | MRW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253432) |
| March 12, 2026 | K252583 | Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220) | A Cute Baby, Inc. | Utah | Substantially Equivalent | 510(k) abbreviated | HGX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252583) |
| March 11, 2026 | K254197 | Picasso Pro Diode Laser (002-00460) | CAO Group, Inc. | Utah | Substantially Equivalent | 510(k) traditional | GEX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254197) |
| March 10, 2026 | P190014/S011 | MyChoice® CDx | Myriad Genetic Laboratories, Inc. | Utah | Approved | PMA 180-day supplement | PJG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190014S011) |
| February 19, 2026 | K260163 | AuST CSP Introducer | CenterPoint Systems, LLC | Utah | Substantially Equivalent | 510(k) special | DYB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260163) |
| February 13, 2026 | K251802 | STAR RF Ablation System | Merit Medical Systems, Inc. | Utah | Substantially Equivalent | 510(k) traditional | GXI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251802) |
| February 12, 2026 | K260177 | Saberscope™ Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1) | Xenocor, Inc. | Utah | Substantially Equivalent | 510(k) special | GCJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260177) |
| January 7, 2026 | K253158 | VyBrate™ VBR System | Vy Spine, LLC | Utah | Substantially Equivalent | 510(k) traditional | MQP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253158) |
| December 19, 2025 | K253161 | Balanced Knee System TriMax Porous Femoral Components | Ortho Development Corp. | Utah | Substantially Equivalent | 510(k) traditional | MBH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253161) |
| December 19, 2025 | K252892 | SCOUT MD Surgical Guidance System | Merit Medical Systems, Inc. | Utah | Substantially Equivalent | 510(k) traditional | NEU | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252892) |
| December 11, 2025 | P240023/S004 | WRAPSODY® Cell-Impermeable Endoprosthesis | Merit Medical Systems, Inc. | Utah | Approved | PMA 180-day supplement | PFV | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240023S004) |
| November 4, 2025 | K250853 | Merit Syringe | Merit Medical Systems, Inc. | Utah | Substantially Equivalent | 510(k) special | FMF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250853) |
| October 27, 2025 | K250520 | OsteoCentric Navigated Instruments System | Osteocentric Technologies, Inc. | Utah | Substantially Equivalent | 510(k) traditional | OLO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250520) |
| October 17, 2025 | K252254 | Osteotomy Wedge System | Sinaptic Surgical | Utah | Substantially Equivalent | 510(k) traditional | PLF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252254) |
| October 14, 2025 | K253331 | PressON Spinal Fixation System | Nexus Spine | Utah | Substantially Equivalent | 510(k) special | NKB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253331) |
| October 8, 2025 | K251422 | BD Saf-T-Intima™ Subcutaneous Catheter System | Becton Dickinson Infusion Therapy Systems, Inc. | Utah | Substantially Equivalent | 510(k) traditional | FOZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251422) |
| October 8, 2025 | K250298 | Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup®... | Clinical Innovations, LLC | Utah | Substantially Equivalent | 510(k) traditional | HDB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250298) |
| September 25, 2025 | K250076 | Endeavor™ Stand-Alone Cervical IBF System | Innovasis | Utah | Substantially Equivalent | 510(k) traditional | OVE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250076) |
| September 10, 2025 | K252527 | Surfacer Inside-Out Access Catheter System | Merit Medical System, Inc. | Utah | Unknown | 510(k) special | QJH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252527) |
| September 5, 2025 | K252478 | Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port... | Bard Access Systems, Inc. | Utah | Substantially Equivalent | 510(k) special | LJT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252478) |
| August 22, 2025 | K250147 | CPS Locator 3D Delivery Catheter | Centerpoint Systems | Utah | Substantially Equivalent | 510(k) traditional | DQY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250147) |
| August 16, 2025 | K251913 | OsteoCentric® UnifiMI® TCS Plating System | OsteoCentric Technologies | Utah | Substantially Equivalent | 510(k) special | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251913) |
| August 14, 2025 | K243544 | BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini | Biofire Diagnostics, LLC | Utah | Substantially Equivalent | De Novo (dual track) | QOF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243544) |
| July 25, 2025 | P850064/S055 | LifePulse High Frequency Ventilator (HFV) | Bunnell, Inc. | Utah | Approved | PMA real-time process supplement | LSZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P850064S055) |
| July 25, 2025 | K243403 | BD Nexiva™ Closed IV Catheter System | Becton Dickinson Infusion Therapy Systems, Inc. | Utah | Substantially Equivalent | 510(k) traditional | FOZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243403) |
| July 23, 2025 | K251265 | Resilience Fully Covered Esophageal Stent System | Merit Medical Systems, Inc. | Utah | Substantially Equivalent | 510(k) traditional | ESW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251265) |
| July 23, 2025 | K251073 | Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation... | Innovasis, Inc. | Utah | Substantially Equivalent | 510(k) traditional | OLO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251073) |
| July 11, 2025 | K251155 | BD Cathena™ Safety IV Catheter | Becton Dickinson Infusion Therapy Systems, Inc. | Utah | Substantially Equivalent | 510(k) traditional | FOZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251155) |
| June 27, 2025 | K251654 | BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™... | Becton Dickinson Infusion Therapy Systems, Inc. | Utah | Substantially Equivalent | 510(k) special | FOZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251654) |
| June 27, 2025 | K250828 | CPS Locator 3D Plus Delivery Catheter | CenterPoint Systems, LLC | Utah | Substantially Equivalent | 510(k) special | DQY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250828) |
| June 18, 2025 | K251253 | PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port... | Bard Access Systems, Inc. | Utah | Substantially Equivalent | 510(k) special | LJT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251253) |
| June 18, 2025 | K250492 | FlexiGo 3D Delivery Catheter | CenterPoint Systems, LLC | Utah | Substantially Equivalent | 510(k) special | DQY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250492) |
| June 3, 2025 | K250682 | BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD... | Becton Dickinson Infusion Therapy Systems, Inc. | Utah | Substantially Equivalent | 510(k) traditional | FOZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250682) |
| May 22, 2025 | K251052 | Trivicta® Hip Stem | Ortho Development Corp. | Utah | Substantially Equivalent | 510(k) traditional | MEH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251052) |
| May 22, 2025 | K250897 | Koala Intrauterine Pressure Catheter (IPC-5000E) | Clinical Innovations, LLC | Utah | Substantially Equivalent | 510(k) traditional | HFN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250897) |
| May 2, 2025 | K250292 | OSPREY Midline Closed IV Catheter System (OspreyEDC-F20) | Skydance Vascular, Inc. | Utah | Substantially Equivalent | 510(k) traditional | FOZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250292) |
| April 30, 2025 | K251051 | AuST Steerable Sheath | CenterPoint Systems, LLC | Utah | Substantially Equivalent | 510(k) special | DYB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251051) |
| April 30, 2025 | K243934 | Stable-L Lumbar Interbody System | Nexus Spine, LLC | Utah | Substantially Equivalent | 510(k) traditional | OVD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243934) |
| April 25, 2025 | K250909 | Prelude Wave Hydrophilic Sheath Introducer | Merit Medical Systems, Inc. | Utah | Substantially Equivalent | 510(k) special | DYB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250909) |
| April 24, 2025 | K250002 | Smart Check O2 (MA0236) | Life Spark Medical, LLC | Utah | Substantially Equivalent | 510(k) traditional | CCL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250002) |
| April 9, 2025 | K242429 | CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System | Becton Dickinson Inc. (Bd) | Utah | Substantially Equivalent | 510(k) traditional | SEF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242429) |
| April 1, 2025 | K243938 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle... | Scientia Vascular, Inc. | Utah | Substantially Equivalent | 510(k) special | MOF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243938) |
| March 24, 2025 | K250603 | AxTiHA® Stand-Alone ALIF System | Innovasis | Utah | Substantially Equivalent | 510(k) special | OVD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250603) |
| March 24, 2025 | K250182 | Innovasis Navigation Instruments | Innovasis, Inc. | Utah | Substantially Equivalent | 510(k) traditional | OLO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250182) |
| March 24, 2025 | K250013 | VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S, VS8-MP90S, VS8-MP100B... | Control Medical Technology, Inc. / Dba Ventiv Scientific | Utah | Substantially Equivalent | 510(k) special | QEZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250013) |
| March 24, 2025 | K243991 | Klassic Knee System - Revision Tibial Baseplate | Total Joint Othopedics, Inc. | Utah | Substantially Equivalent | 510(k) traditional | JWH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243991) |
| March 21, 2025 | K243185 | REMI Remote EEG Monitoring System | Epitel | Utah | Substantially Equivalent | 510(k) traditional | OMC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243185) |
| March 18, 2025 | K250494 | The OsteoCentric Bone Plate and Screw System | OsteoCentric Technologies | Utah | Substantially Equivalent | 510(k) special | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250494) |
| March 18, 2025 | K241783 | FortiVy™ OsteoVy™ Lumbar IBF | Vy Spine, LLC | Utah | Substantially Equivalent | 510(k) traditional | MAX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241783) |
| March 14, 2025 | K242244 | Viewer+ | Lumea, Inc. | Utah | Substantially Equivalent | 510(k) traditional | QKQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242244) |
| March 12, 2025 | K243822 | BioFire Warrior Panel; BioFire Warrior Panel Control Kit | Biofire Defense, LLC | Utah | Substantially Equivalent | 510(k) traditional | PRD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243822) |
| February 27, 2025 | K241586 | PIVO™ Pro Needle-free Blood Collection Device | Becton Dickinson Infusion Therapy Systems, Inc. | Utah | Substantially Equivalent | 510(k) traditional | JKA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241586) |
| February 26, 2025 | K250346 | BonVie+ | Elute, Inc. | Utah | Substantially Equivalent | 510(k) special | MQV | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250346) |
| February 12, 2025 | P240023/S002 | WRAPSODY Cell-Impermeable Endoprosthesis | Merit Medical Systems, Inc. | Utah | Approved | PMA 180-day supplement | PFV | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240023S002) |
| February 12, 2025 | P240023/S001 | WRAPSODY Cell-Impermeable Endoprosthesis | Merit Medical Systems, Inc. | Utah | Approved | PMA 180-day supplement | PFV | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240023S001) |
| January 16, 2025 | K243885 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid | Biofire Diagnostics, LLC | Utah | Substantially Equivalent | 510(k) special | PCH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243885) |
| January 15, 2025 | K242873 | Ventrax™ Delivery System | Merit Medical Systems, Inc. | Utah | Substantially Equivalent | 510(k) special | DQY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242873) |
| January 15, 2025 | K242229 | Micro Ace Gold Advanced Micro Access System | Merit Medical Systems, Inc. | Utah | Substantially Equivalent | 510(k) traditional | DRE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242229) |
| December 20, 2024 | K243759 | BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack)) | Biofire Diagnostics, LLC | Utah | Substantially Equivalent | 510(k) special | PEN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243759) |
| December 19, 2024 | P240023 | WRAPSODY® Cell-Impermeable Endoprosthesis | Merit Medical Systems, Inc. | Utah | Approved | PMA original approval | PFV | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240023) |
| December 10, 2024 | K241521 | Prelude Small O.D. Introducer Guide Wire | Merit Medical Systems, Inc. | Utah | Substantially Equivalent | 510(k) traditional | DQX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241521) |
| December 5, 2024 | K243463 | BIOFIRE FILMARRAY Tropical Fever Panel | Biofire Diagnostics, LLC (Biomerieux) | Utah | Substantially Equivalent | 510(k) special | QMV | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243463) |
| December 4, 2024 | K243180 | SSPC NXT Delivery Catheter | CenterPoint Systems, LLC | Utah | Substantially Equivalent | 510(k) special | DQY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243180) |
| December 4, 2024 | K242301 | Socrates 38 Catheter | Scientia Vascular, Inc. | Utah | Substantially Equivalent | 510(k) traditional | QJP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242301) |
| November 27, 2024 | K241353 | PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set | Bard Access Systems, Inc. | Utah | Substantially Equivalent | 510(k) traditional | PTI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241353) |

## Applicants with the most decisions

| Applicant | Decisions | Latest |
| --- | --- | --- |
| Merit Medical Systems, Inc. | 16 | July 27, 2026 |
| CenterPoint Systems, LLC | 9 | July 29, 2026 |
| Becton Dickinson Infusion Therapy Systems, Inc. | 7 | April 2, 2026 |
| Scientia Vascular, Inc. | 5 | August 6, 2026 |
| Biofire Diagnostics, LLC | 4 | October 21, 2026 |
| Vy Spine, LLC | 4 | March 27, 2026 |
| OsteoCentric Technologies | 3 | October 2, 2026 |
| Bunnell, Inc. | 3 | September 28, 2026 |
| Bard Access Systems, Inc. | 3 | September 5, 2025 |
| Biofire Defense, LLC | 2 | July 17, 2026 |
| Ultradent Products, Inc. | 2 | July 1, 2026 |
| Nexus Spine | 2 | June 22, 2026 |
| Ortho Development Corp. | 2 | December 19, 2025 |
| Clinical Innovations, LLC | 2 | October 8, 2025 |
| Innovasis | 2 | September 25, 2025 |
| Innovasis, Inc. | 2 | July 23, 2025 |
| Bloom Surgical, Inc. | 1 | October 29, 2026 |
| Nexus CMF, LLC | 1 | October 9, 2026 |
| Biofire Diagnostics | 1 | September 22, 2026 |
| Scientia Vascular | 1 | September 16, 2026 |

## By panel

| Panel | Decisions | Latest |
| --- | --- | --- |
| [Cardiovascular](https://specstream.ai/data/fda-clearances/panel/cardiovascular) | 31 | September 16, 2026 |
| [Orthopedic](https://specstream.ai/data/fda-clearances/panel/orthopedic) | 20 | October 9, 2026 |
| [General Hospital](https://specstream.ai/data/fda-clearances/panel/general-hospital) | 12 | April 2, 2026 |
| [Microbiology](https://specstream.ai/data/fda-clearances/panel/microbiology) | 7 | October 21, 2026 |
| [Neurology](https://specstream.ai/data/fda-clearances/panel/neurology) | 5 | February 13, 2026 |
| [Anesthesiology](https://specstream.ai/data/fda-clearances/panel/anesthesiology) | 4 | September 28, 2026 |
| Unknown | 3 | June 24, 2026 |
| [Obstetrics/Gynecology](https://specstream.ai/data/fda-clearances/panel/obstetrics-gynecology) | 3 | March 12, 2026 |
| [General, Plastic Surgery](https://specstream.ai/data/fda-clearances/panel/general-plastic-surgery) | 3 | March 11, 2026 |
| [Gastroenterology, Urology](https://specstream.ai/data/fda-clearances/panel/gastroenterology-urology) | 2 | October 29, 2026 |
| [Dental](https://specstream.ai/data/fda-clearances/panel/dental) | 2 | July 1, 2026 |
| [Radiology](https://specstream.ai/data/fda-clearances/panel/radiology) | 2 | May 29, 2026 |
| [Pathology](https://specstream.ai/data/fda-clearances/panel/pathology) | 2 | March 10, 2026 |
| [Immunology](https://specstream.ai/data/fda-clearances/panel/immunology) | 1 | March 12, 2025 |
| [Clinical Chemistry](https://specstream.ai/data/fda-clearances/panel/clinical-chemistry) | 1 | February 27, 2025 |

## By decision type

| Decision type | Decisions | Latest |
| --- | --- | --- |
| [510(k) traditional](https://specstream.ai/data/fda-clearances/decision/510k-traditional) | 54 | October 29, 2026 |
| [510(k) special](https://specstream.ai/data/fda-clearances/decision/510k-special) | 32 | October 2, 2026 |
| [PMA 180-day supplement](https://specstream.ai/data/fda-clearances/decision/pma-180-day-supplement) | 5 | September 28, 2026 |
| [De Novo (dual track)](https://specstream.ai/data/fda-clearances/decision/de-novo-dual-track) | 2 | October 21, 2026 |
| [PMA 30-day notice](https://specstream.ai/data/fda-clearances/decision/pma-30-day-notice) | 2 | June 11, 2026 |
| [510(k) abbreviated](https://specstream.ai/data/fda-clearances/decision/510k-abbreviated) | 1 | March 12, 2026 |
| [PMA real-time process supplement](https://specstream.ai/data/fda-clearances/decision/pma-real-time-process-supplement) | 1 | July 25, 2025 |
| [PMA original approval](https://specstream.ai/data/fda-clearances/decision/pma-original-approval) | 1 | December 19, 2024 |

## 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/).