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 |
|---|---|---|---|---|---|
| K201825 | MiniCAT 2D | Xoran Technologies, LLC | KPR | Class II | |
| K201815 | Dornier MAGELLAN Ureteral Access Sheath | Dornier Medtech America, Inc. | FED | Class II | |
| K201526 | TIPCAM1 Rubina Video Endoscope System | Karl Storz Endoscopy-America, Inc. | GCJ | Class II | |
| K201404 | Passio Pump Drainage System | Bearpac Medical, LLC | DWM | Class II | |
| K201325 | Optomed Smartscope M5 with Optomed Smartscope FA | Optomed Oyj | HKI | Class II | |
| K201158 | NeuroStar Advanced Therapy | Neuronetics Inc. | OBP | Class II | |
| K200873 | Halo | NICo-Lab B.V. | QAS | Class II | |
| K193576 | Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | POL | Class II | |
| K193346 | Codman Surgical Patties & Strips | Integra LifeSciences Corporation | HBA | Class II | |
| K193287 | CorInsights MRI | Adm Diagnostics, Inc. | LLZ | Class II | |
| K193285 | V-Onestep | VITROMED GmbH | MQL | Class II | |
| K193191 | MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag | Weinmann Emergency Medical Technology GmbH + Co. KG | BTL | Class II | |
| K193056 | Puritan Bennett 980 Series Ventilator System | Medtronic, Inc. | CBK | Class II | |
| DEN200043 | FilmArray Global Fever Panel | BioFire Defense, LLC | QMV | Class II | |
| K203167 | DePuy Corail AMT Hip Prosthesis | Depuy Orthopaedics Inc. | LZO | Class II | |
| K203008 | DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System | Cardiovascular Systems Incorporated | MCW | Class II | |
| K202980 | Laser Therapy Device | Shenzhen Leaflife Technology Co., Ltd. | GEX | Class II | |
| K202442 | Carewear Firefly Wrinkle Reduction | Carewear Corp. | OHS | Class II | |
| K202172 | StarWalker | Fotona d.o.o. | GEX | Class II | |
| K201867 | Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System | Baxter Healthcare Corporation | FKX | Class II | |
| K201694 | Air Compression Therapy Device | Shenzhen Dongjilian Electronics Co., Ltd. | IRP | Class II | |
| K200693 | K2 Mobile | Hulaser, Inc. | GEX | Class II | |
| K200580 | FotoDent denture | Dreve Dentamid GmbH | EBI | Class II | |
| K200171 | SMR TT Augmented Glenoid System | Lima Corporate S.p.A. | PHX | Class II | |
| K192860 | Sapphire Infusion Pump, Sapphire administration sets | Q Core Medical, Ltd. | FRN | Class II | |
| K192503 | GM501 Wash with Phenol Red and Gentamicin | Hamilton Thorne Incorporated | MQL | Class II | |
| K203287 | Dbswin, Vistaeasy | Durr Dental SE | LLZ | Class II | |
| K203187 | HiRise | CurveBeam, LLC | JAK | Class II | |
| K203138 | FIREBIRD SI Fusion System | Orthofix SRL | OUR | Class II | |
| K202821 | Indigo Aspiration System - Aspiration Catheter 12 and Separator 12 | Penumbra Inc. | QEW | Class II | |
| K202800 | Pacific Plus PTA Catheter | Medtronic Vascular,Inc(Formerly D.B.A Ev3 Inc.,Covidien, LLC) | LIT | Class II | |
| K202713 | TrueView 100 Pro | Compai Healthcare (Shenzhen) Co.,Ltd | MWP | Class II | |
| K202535 | Arthrex FastThread Interference Screw | Arthrex GmbH | MAI | Class II | |
| K202503 | Chrome | Quanta System Inc. | GEX | Class II | |
| K202449 | Signature Latex LT, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm² per glove of Extractable Protein | MEDLINE INDUSTRIES, LP - Northfield | KGO | Class I | |
| K202233 | Venue Go | GE Healthcare | IYN | Class II | |
| K202150 | GlidePath 7.5F Long-Term Dialysis Catheter | C.R. Bard Inc | MSD | Class II | |
| K201382 | X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology) | De Gotzen S.r.l. | OAS | Class II | |
| K201195 | syngo.via MI Workflows, syngo MBF | Siemens Medical Solutions USA, Inc. | QIH | Class II | |
| K201019 | Genius AI Detection | Hologic, Inc. | QDQ | Class II | |
| K200912 | Freedom(R) - TiNbN Coated Knee | Maxx Orthopedics Inc. | JWH | Class II | |
| K200472 | Viveve System | Viveve Medical, Inc. | GEI | Class II | |
| K193010 | Liebel-Flarsheim IBP Transfer Set | Mallinckrodt, Inc. | PQH | Class II | |
| K202931 | Disposable Trocar | Wuxi Shukang Medical Appliance Co., Ltd. | GCJ | Class II | |
| K202777 | VeriFixx™ Small Bone Implant | Armis Biopharma, Inc. | HTY | Class II | |
| K202444 | Knotless TensionTight Button Implant System | Arthrex GmbH | MBI | Class II | |
| K202307 | Activ Fuse | Newclip Technics | HRS | Class II | |
| K201998 | JETi AIO Peripheral Thrombectomy System | Walk Vascular, LLC | QEZ | Class II | |
| K200992 | S.I.N. Dental Implant System | S.I.N. Implant System Ltda | DZE | Class II | |
| K200612 | R501 aortic root cannula without vent line, R502 aortic root cannula with vent line | Corcym Inc. | DWF | Class II |