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 |
|---|---|---|---|---|---|
| K945825 | Secure Safety Insert | Syncor Intl. Corp. | FMI | Class II | |
| K945808 | Running Sunglasses | Million HU Corp. | HQY | Class I | |
| K945793 | P.f.c.(r) Bipolar Hip System - 22Mm Bipolar | Johnson & Johnson Professionals, Inc. | KWY | Class II | |
| K945761 | Low Temperature Cautery Fine Tip, Adjustable, Replaceable Tip | Apyx Medical Corporation | HQP | Class II | |
| K944836 | Osteonics Restoration Monolithic II Hip Stem Series | Osteonics Corp. | MEH | Class II | |
| K944763 | Cut-Tec or Wells Lamont Polyester/wire Cut-Resistant Glove Liner Wells-Tec, Scepter | Wells Lamont Corp. | LYU | Class I | |
| K944610 | Olympus Ultrasonic Probes | OLYMPUS Corporation of the Americas | ITX | Class II | |
| K944481 | The Heart Protector | Garan Scientific, Inc. | NXB | Class I | |
| K944350 | Sc 6000/ Sc 6000P/ R50 | Siemens Medical Solutions USA, Inc. | DSI | Class II | |
| K944302 | The Flex-Set Subcutaneous Infusion Set | Cathco, Inc. | FOZ | Class II | |
| K943983 | Il Test Digoxin & Il Test Digoxin Calibrators | Instrumentation Laboratory Co. | KXT | Class II | |
| K943770 | Low Volume Multiport | B. Braun of America, Inc. | FPA | Class II | |
| K943661 | Sterile Physiological Saline/sterile Water | Medcare Custom Packaging, Inc. | JOL | Class II | |
| K943259 | 1085 Ultimate E Plethysmograph | Medical Graphics Corp. | CCM | Class II | |
| K943186 | Capset Calcium Sulfate Bone Graft Plaster | Lifecore Biomedical LLC | LYC | Class II | |
| K943038 | Statlock-Ipidural | Venetec, Inc. | FPA | Class II | |
| K940772 | Echo(tm) (Quad(tm) 7000 Magnetic Resonance Imaging Scanner) | Fonar Corp. | LNH | Class II | |
| K933177 | Siemens Sirecust 700 Bedside Monitor Modifications | Siemens Medical Solutions USA, Inc. | DSI | Class II | |
| K951338 | Indirect Ophthalmoscope Video System Io0 a Tv | Neitz Instruments Company, Ltd. | HLI | Class II | |
| K951196 | Fnl-10P, Fiber Nasoparhyngoscope | Pentax Precision Instrument Corp. | EOB | Class II | |
| K951180 | Esstech Sv (Polymacon) Soft (Hydrophilic) Contact Lens | Szabocsik and Assoc. | LPL | Class II | |
| K951035 | Bipolar Forceps | Megadyne Medical Products, Inc | GEI | Class II | |
| K950908 | Fst Cath-Ud, Catheter | Fiberoptic Sensor Technlogies, Inc. | FEN | Class II | |
| K950878 | Menicon Sp Vial | Hyman, Phelps & McNamara, P.C. | LRX | Class II | |
| K950530 | Pro-Tec-Case | Hyman, Phelps & McNamara, P.C. | LRX | Class II | |
| K945721 | Penn-Pet Scanner | Ugm Medical Systems, Inc. | KPS | Class II | |
| K944279 | At-III Calibrator | American Bioproducts Co. | JBQ | Class II | |
| K943178 | Delta | Venture Management Corp. | LPL | Class II | |
| K940848 | Gelflex | Venture Management Corp. | LPL | Class II | |
| K940328 | Prime Cemented Hip System | Orthopaedic Innovations, Inc. | JDI | Class II | |
| K935043 | Siemens Clinical Work Station | Siemens Medical Electronics | DQK | Class II | |
| K951353 | Hybrid Surgical Devices, Modificiation | Laser Centers of America, Inc. | GEI | Class II | |
| K951229 | Modified Biopsy Needle | Biopsys Medical, Inc. | KNW | Class II | |
| K951201 | Karl Storz Nasal,, Tonsil, Ear, Laryngeal Snare | Karl Storz Endoscopy-America, Inc. | EOB | Class II | |
| K951195 | Fi-10P | Pentax Precision Instrument Corp. | CAL | Class I | |
| K951194 | Fi-10M | Pentax Precision Instrument Corp. | CAL | Class I | |
| K951149 | Single Use Instrument Tray | Medcare Custom Packaging, Inc. | LRO | Class II | |
| K951104 | Endoboot | United States Endoscopy Group, Inc. | OCU | Class II | |
| K951053 | Angiorex Cat-350B | Toshiba America Medical Systems, In.C | IZZ | Class II | |
| K951046 | Rusch Endotest Cuff Pressure Monitor | Rusch Intl. | BSK | Class II | |
| K951032 | Finess I (Dermatologic Application) | Utah Medical Products, Inc | GEI | Class II | |
| K950787 | Welch Allyn Otoscope | Welch Allyn Inc | ERA | Class I | |
| K950725 | Sharplan Model 1015 CO2 Laser | Sharplan Lasers, Inc. | GEX | Class II | |
| K950667 | Aztech 65 with Ccd (Computer Controlled Density) Timer | Chicago X-Ray Systems, Inc. | EAP | Class II | |
| K950339 | Ksea Steiner Electromechanic Morcellator | Karl Storz Endoscopy-America, Inc. | GCJ | Class II | |
| K950243 | Titan Insufflation Needle | Endolap, Inc. | GCJ | Class II | |
| K950140 | Is-1/Quadripolar Terminal Cap, Part Number 6011069 | Pacesetter, Inc. | DTD | Class II | |
| K950068 | Carbon Fiber Couch Insert | Medtec LLC | KXJ | Class II | |
| K946105 | Electrosurgical Cutting & Coagulation Device & Accessories | Endoscopic Technologies, Inc. | GEI | Class II | |
| K945798 | Mrt-35A Upgrade 8.0Cd | Toshiba America Mri, Inc. | LNH | Class II |