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 |
|---|---|---|---|---|---|
| K062734 | Adjust-Right Fixation Devices | Valpo Orthopedic Technology, Inc. | JDR | Class II | |
| K062684 | Excia Total Hip System 36Mm Ceramic Head | Aesculap Inc | LZO | Class II | |
| K062638 | Tampax Compak Pearl Plastic Applicator Scented and Unscented Tampons | Procter & Gamble Co. | HEB | Class II | |
| K062637 | Vitros Chemistry Products Metd Reagent, Calibrator Kit 26, Dat Performance, Verifiers I, II, III, IV & V | Ortho-Clinical Diagnostics, Inc. | DJR | Class II | |
| K062593 | Cardiac Markers Control and Calibration Verification Control Set | Compass Bioscience | JJY | Class I | |
| K062515 | Retention Flow Opaque | Kulzer GmbH | EBF | Class II | |
| K062507 | Micro-Infusion System | Ekos Corp. | QEY | Class II | |
| K062467 | Axsym Holo Tc Reagent Kit, Model 3L83-20; Standard Calibrator Kit, Model 3L83-01; Control Kit, Model 3L83-10 | Axis-Shield Diagnostics, Ltd. | CDD | Class II | |
| K062347 | Ascensia Breeze 2 Blood Glucose Monitoring System | Medrad, Inc. | NBW | Class II | |
| K062270 | Radius Spinal System | Howmedica Osteonics Corp | NKB | Class II | |
| K062233 | Heartstart Mrx Monitor/defibrillator | Philips North America LLC | MKJ | Class III | |
| K062094 | Vitros Chemistry Products Pcp Reagent, Calibrator Kit 26, Fs Calibrator 1, Dat Performance Verifiers I, II, III, IV, & V | Ortho-Clinical Diagnostics, Inc. | LCM | Unclassified | |
| K062077 | Vitros Chemistry Products Amph Reagent; Calibrator Kit 26; Fs Calibrator 1; Dat Performance Verifiers | Ortho-Clinical Diagnostics, Inc. | DKZ | Class II | |
| K061951 | Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model Xpeedior 120 | Possis Medical, Inc. | QEZ | Class II | |
| K061948 | Proclear (Omafilcon a) Daily Disposable/daily Wear Soft Contact Lens | CooperVision, Inc. | MVN | Class II | |
| K061892 | Propatch Soft Tissue Repair Matrix | Artivion, Inc. | FTM | Class II | |
| K061749 | Eclipse Total Ankle Implant | Kinetikos Medical, Inc. | HSN | Class II | |
| K061617 | Forsure One Step Dip & Read (X) Drug Screen Test | Tianjin New Bay Bioresearch Co., Ltd. | DKZ | Class II | |
| K061608 | Modification to Eub-5500 Diagnostic Ultrasound Scanner | Hitachi Medical Corp. | IYN | Class II | |
| K061567 | Biohorizons Ceramic Abutment | BioHorizons Implant Systems Inc | NHA | Class II | |
| K061517 | Precision Press Tack / Intraderm, Seven Star and Acupuncture Needles; Alpha and Fine Point Acupuncture Needles | Prime Herbs Corporation | MQX | Class II | |
| K063467 | Smith & Nephew RF Cannulae | Smith & Nephew, Inc. | GXI | Class II | |
| K063422 | Bioaggregate | Innovative BioCeramix, Inc | KIF | Class II | |
| K063361 | Excelart Vantage Atlas, Model Mrt-1503 | Toshiba America Medical Systems, In.C | LNH | Class II | |
| K063333 | M3 | Mavig GmbH | FSY | Class II | |
| K063291 | Infrared Ear Thermometer, Model Irt-21 and Irt-22 | Choice Smart Health Care Co., Ltd. | FLL | Class II | |
| K063240 | Sherlock Tls Stylet, Sherlock Tls Detector | C.R. Bard Inc | LJS | Class II | |
| K063234 | On-Q Introducers | Halyard Health | BSO | Class II | |
| K063193 | Modification to Biomarc Tissue Marker | Carbon Medical Technologies, Inc. | NEU | Class II | |
| K063178 | Bard Collamend Implant, Models 1175102, 1175103, 1175104, 1175105, 1175106 | C.R. Bard Inc | FTM | Class II | |
| K063161 | Skintact Cool Contact Electrosurgical Grounding Plate with Nh 04 Gel | Leonhard Lang GmbH | GEI | Class II | |
| K062945 | Bd Phoenix Automated Microbiology System - Ertapenem (Gn) 0.25-32 Ug/ml | Becton Dickinson & Co | LON | Class II | |
| K062822 | Vari-Lase Endovenous Laser Console, Model 7500 | Vascular Solutions LLC | GEX | Class II | |
| K062781 | Mod1 Compensators for Radiation Beam Therapy | Symtium Corporation | IXI | Class II | |
| K062721 | Greenton Ecolite Ipl System | Greenton (London), Ltd. | GEX | Class II | |
| K062683 | Enamel Pro Varnish | Premier Dental Products Co | LBH | Class II | |
| K062662 | Telemedicine System Model Vms-01 | Medic4all (Israel), Ltd. | DRG | Class II | |
| K062571 | Longport Episcan, Model-I-200 | Longport, Inc. | IYO | Class II | |
| K062500 | Flexpen Needle | Novo Nordisk a/S | FMI | Class II | |
| K062413 | Aesculap Pneumatic Kerrison | Aesculap Inc | HAD | Class II | |
| K062212 | Silver Shield Antimicrobial Skin and Wound Gel, Model 3015-S | Anacapa Technologies, Inc. | FRO | Unclassified | |
| K062183 | Farrzyme Human High Avidity Anti-Dsdna Enzyme Immunoassay Kit | The Binding Site | LRM | Class II | |
| K062166 | Enamel Pro | Premier Dental Products Co | EJR | Class I | |
| K062153 | Portable Oxygen Generator System | Molecular Products Inc | CAW | Class II | |
| K062044 | The 5.0 X 6.0Mm Dental Implant | Bicon, LLC | DZE | Class II | |
| K061983 | Stimuplex Pen | Stockert GmbH | BXN | Class II | |
| K061794 | Fidis Tm Thyro, Model Mx002 | Biomedical Diagnostics (Bmd) SA | JZO | Class II | |
| K061705 | Cadwell Easynet Nasal Pressure Module | Cadwell Laboratories, Inc. | MNR | Class II | |
| K060054 | Oncobionic System | Oncobionics, Inc. | OAB | Class II | |
| K050263 | Millennium Series, Including Millennium B, B+, B2 and Bu | M.O. Com S.r.l. | FLE | Class II |