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 | 2,732 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K913653 | 3M Anti-Dsdna Fast Test | 3M Diagnostic Systems, Inc. | LRM | Class II | |
| K913616 | Lsf Diagnostic Related Group Cemented Hip | Implant Technology, Inc. | JDI | Class II | |
| K913573 | Safety Plus Dental Injection Needle | Specialites Septodont | DZM | Class I | |
| K913559 | Osteo Complete Pneumatic Drill-Oscilair | Osteo AG | HSZ | Class I | |
| K913558 | Reliable Cone Style Face Mask | Anago, Inc. | FXX | Class II | |
| K913533 | Model M1403a Telemetry Monitoring Systems (Tms) | Hewlett-Packard Co. | DXH | Class II | |
| K913357 | One Touch(r) II Hospital Blood Glucose Monit Syst | Lifescan, Inc. | CGA | Class II | |
| K913176 | Delphin II Centrifugal System | 3M Health Care, Sarns | KFM | Class II | |
| K913131 | Human Beta-2 Microglobin En-Rid Kit | The Binding Site | JZG | Class II | |
| K913119 | Varian C-Series Clinacs (Clinac 2300C/d) | Varian Assoc., Inc. | IYE | Class II | |
| K912730 | Rocket Surgical Skin Marking Pen | West Texas Lighthouse for the Blind | FZZ | Class I | |
| K912404 | Transesophageal Transducer Thermal Safety | Hewlett-Packard Co. | DPT | Class II | |
| K911926 | Polaris, Ophthalmology | Pfizer Laser Systems | GEX | Class II | |
| K911871 | Cardiodyne Kinetorr/pc Blood Pressure Monitors | Cardiodyne, Inc. | DXN | Class II | |
| K911734 | Teartec Rapid Lacrimal Assesment System | Northland Cataract & Eye Care Clinic | KYD | Class I | |
| K910978 | Accu-Beam Laparoscopic System | Tti Medical | GEI | Class II | |
| K910257 | Baxa Pca Infusor | Baxa Corp., Sub. of Cook Group, Inc. | MEA | Class II | |
| K905608 | Indirect Fluorescent Assay for Herpes Simplex 1 | Stellar Bio Systems, Inc. | GQL | Class II | |
| K905276 | Therma-H | Kure Swiss Medical AG Corp. | LKX | Unclassified | |
| K913523 | Auto. Oscillometric Digital Blood Press. Monitor | Omron Healthcare Co., Ltd. | DXN | Class II | |
| K914800 | P54 Bte Hearing Aid | Philips Hearing Instruments Co. | ESD | Class I | |
| K914725 | Coordinator, Cable Input | Cardiotronics, Inc. | DPS | Class II | |
| K914689 | Hearing Aid, Unitron Model Vista 4000 | Unitron Industries, Inc. | ESD | Class I | |
| K914688 | Hearing Aid, Unitron Model Vista 3000 | Unitron Industries, Inc. | ESD | Class I | |
| K914450 | Gore-Tex(r) Surgical Membrane, Process Change | W. L. Gore & Associates, Inc. | DXZ | Class II | |
| K914448 | Gore-Tex(r) Cardiovascular Patch, Process Change | W. L. Gore & Associates, Inc. | DXZ | Class II | |
| K914447 | Gore-Tex(r) Vascular Grafts, Process Change | W. L. Gore & Associates, Inc. | DSY | Class II | |
| K914165 | X-Ray Table | Siemens Medical Solutions USA, Inc. | IXR | Class II | |
| K913837 | Microscis(tm) Introcular Scissor System | Vision Medical Inc | HQE | Class II | |
| K913786 | Flexiflo Over-the-Guidewire Gast Kit W/cr-Bar Bump | Abbott Medical | KNT | Class II | |
| K913764 | Abbott Quickstart Magnesium Test, Item #5A32 | Em Diagnostic Systems, Inc. | JGJ | Class I | |
| K913747 | Stayfree(tm) Maxi-Pad | Personal Products Co. | HHD | Class I | |
| K913697 | Automatic Corneal Shaper | Hansa Research & Development, Inc. | HNO | Class I | |
| K913589 | Earscan Dsp-1 Pure Tone Audiometer | Micro Audiometrics Corporation | EWO | Class II | |
| K913577 | Milestone Ms 325 Radiographic X-Ray Generator | Control-X, Inc. | IZO | Class I | |
| K913517 | Isolate Infusion Cathetr System | Lake Region Mfg., Inc. | DQY | Class II | |
| K913514 | Electrosurgical Unit Cable | Kirwan Surgical Products, LLC | GEI | Class II | |
| K913391 | Tegwire (Tm) | Boston Scientific Corporation | LIT | Class II | |
| K913366 | In-the-Ear Hearing Aids | Fenwick Hearing Instruments | ESD | Class I | |
| K913174 | Varian Clinac 600Sr | Varian Assoc., Inc. | IYE | Class II | |
| K913098 | Apiration Biopsy Syringe Gun, Cat. Code #54501 | Dlp, Inc. | KNW | Class II | |
| K913074 | 0.016 Guide Wire for Neurological Endoscope | Terumo Medical Corp. | DQX | Class II | |
| K913041 | Anti-Dsdna Antibody Test | Helix Diagnostics, Inc. | LLL | Class II | |
| K912969 | Torque Fitting | Freedom Machine, Inc. | DTL | Class II | |
| K912909 | Solair (Tm) Infant Incubator Transparent Hood Warm | Air-Shields Vickers, Inc. | FMZ | Class II | |
| K912893 | Orthopantomograph 100 | Instrumentarium Corp. | EHD | Class II | |
| K912477 | Itc Coaxial Angiographic Cath Set, Modification | Interventional Therapeutics Corp. | DQO | Class II | |
| K912250 | Isorad(tm) Integral Buildup Photon Diodes | Theta Systems, Inc. | IWB | Class II | |
| K911974 | Pgk Stereotactic Device | Northern Virginia Radiology and Nuclear Medicine | HRX | Class II | |
| K910997 | Datascope Percor Stat Intra-Aortic Balloon | Datascope Corp. | DSP | Class II |