510(k) clearances
Premarket notifications cleared by FDA, newest decision first.
Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.
Data as of , the FDA export date. FDA 510(k) database
Clearances by decision year
Last 15 yearsShow the numbers
| Year | Clearances |
|---|---|
| 2012 | 3,135 |
| 2013 | 3,052 |
| 2014 | 3,202 |
| 2015 | 3,020 |
| 2016 | 2,956 |
| 2017 | 3,200 |
| 2018 | 3,062 |
| 2019 | 2,918 |
| 2020 | 2,923 |
| 2021 | 3,023 |
| 2022 | 3,209 |
| 2023 | 3,346 |
| 2024 | 3,129 |
| 2025 | 3,225 |
| 2026 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K182272 | Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis | Sterilmed Inc | NLQ | Unclassified | |
| K181844 | One Touch | Thai Nippon Rubber Industry Public Company Limited | HIS | Class II | |
| K181673 | Rigi10 Malleable Penile Prosthesis | Rigicon AS | FAE | Class II | |
| K190690 | INSPIRE 7 Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir, INSPIRE 7M Hollow Fiber Oxygenator, INSPIRE 7 Dual Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir | Corcym Inc. | DTZ | Class II | |
| K190664 | RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review | Brainlab, Inc. | MUJ | Class II | |
| K190658 | MIS Bunion Plating System | Crossroads Extremity Systems LLC | HRS | Class II | |
| K190626 | SyncVision System | Volcano Corporation | OWB | Class II | |
| K190365 | Baby Gorilla/Gorilla Plating System | Paragon 28 | HRS | Class II | |
| K190079 | ArgenZ HT+ | The Argen Corporation | EIH | Class II | |
| K183599 | Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter | Nipro Vascular Innovations Americas, Inc. | OGZ | Class II | |
| K183490 | Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Balance Biosurface | Medtronic, Inc. | DTZ | Class II | |
| K183202 | Deep Learning Image Reconstruction | GE Healthcare | JAK | Class II | |
| K183015 | PuraSinus | 3-D Matrix, Inc. | NHB | Class II | |
| K182891 | TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants | CS Medical LLC | PSW | Class II | |
| K182737 | 3T 32 Channel Head Coil | Nova Medical, Inc | MOS | Class II | |
| K182640 | Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Blue and Violet Blue) | Shandong Hengya Packaging Printing Co.,Ltd | LZA | Class I | |
| K182619 | ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel | Genmark Diagnostics, Incorporated | PEN | Class II | |
| K182572 | InstaRISPACS / InstaZFP / InstaMobi v5.0 | Meddiff Technologies Pvt., Ltd. | LLZ | Class II | |
| K182396 | KardiaMobile, KardiaStation | AliveCor | DXH | Class II | |
| K181915 | PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit | Ixensor Co Ltd | LCP | Class II | |
| K181912 | Ascent Cardiorespiratory Diagnostic Software | Medical Graphics Corp. | BTY | Class II | |
| K180757 | D-Clip; D-Clip Applier | Peter Lazic GmbH | HCH | Class II | |
| DEN180060 | Plenity | Gelesis SRL | QFQ | Class II | |
| K190786 | Eye Prime | Ellex Medical Pty Ltd | IYO | Class II | |
| K190453 | VisCalor bulk | Voco GmbH | EBF | Class II | |
| K190317 | Zavation Spinal System | Zavation Medical Products, LLC | NKB | Class II | |
| K190070 | Sonopet iQ Ultrasonic Aspirator System | Stryker Corp. | LFL | Unclassified | |
| K190058 | PureSleep (OTC use) | Sleep Science Partners, Inc. | LRK | Class II | |
| K183526 | Codman Electrosurgical Generator, Foot Pedal | Kls Martin GmbH + Co. KG | GEI | Class II | |
| K183398 | Endoform Restella | AROA Biosurgery Inc. | FTM | Class II | |
| K181758 | ELRA Electrode | Starmed Co.,Ltd | KNS | Class II | |
| K181361 | Brux Night Guard | Brux Night Guard | MQC | Unclassified | |
| K181296 | Syntec Femoral Nail System | Syntec Scientific Corp. | HSB | Class II | |
| K190631 | M.U.S.T. MINI Posterior Cervical Screws System | Medacta International SA | NKG | Class II | |
| K190295 | Confirm Rx Insertable Cardiac Monitor | Abbott (St. Jude Medical) | MXC | Class II | |
| K190175 | S-Mak Xl | Merit Medical Systems, Inc. | DRE | Class II | |
| K183306 | GLUCOCARD® W onyx Blood Glucose Monitoring System | ARKRAY Factory, Inc. | NBW | Class II | |
| K183057 | PUMA-G System | CoapTech, Inc. | KGC | Class II | |
| K182662 | NAV PAK Needle, NIM NAV PAK Needle | Boston Endo Surgical Tech | PDQ | Class II | |
| K182582 | Oryum and Ovem Epidermal Deri Prick Test Applicator | Allergy & Applicator Depot, LLC | SCL | Class II | |
| K181110 | PROPHYflex 4 | Kaltenbach & Voigt GmbH | EFB | Class I | |
| K190653 | ExcelsiusGPS | Globus Medical, Inc. | OLO | Class II | |
| K190327 | ENConnect 40 mm Screw Cap to ENPlus Adapter | Cedic S.r.l. | PIF | Class II | |
| K183660 | DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | IYN | Class II | |
| K182770 | Adult Intraosseous Infusion Device | Einstein Works, LLC | FMI | Class II | |
| K182341 | Pantheris SV | Avinger, Inc. | MCW | Class II | |
| K182333 | Vera | Reflexion Health, Inc. | LXJ | Class II | |
| K181832 | Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device | Guangdong Transtek Medical Electronics Co.,Ltd | DXN | Class II | |
| K190611 | Vivix-S 1751S | Vieworks Co., Ltd. | MQB | Class II | |
| K190040 | Straumann BLX Line Extension - New Abutments | Straumann USA, LLC | NHA | Class II |