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 |
|---|---|---|---|---|---|
| K082269 | Visage Pacs, Version 6.0/Cs 3.1 | Visage Imaging, Inc | LLZ | Class II | |
| K082248 | Sta Satellite Automated Multi-Parameter Analyzer | Diagnostica Stago, Inc. | JPA | Class II | |
| K082090 | 9131 Defibrillation Electrodes | ZOLL Medical Corporation | MKJ | Class III | |
| K081852 | Truly Automatic Blood Pressure Monitor, Model Db11 | Truly Instrument Limited | DXN | Class II | |
| K081095 | Prolite III Tower and Pr and Hr Handpiece | Quantel S.A. | GEX | Class II | |
| K072831 | Frog | Newby-Coombs, LLC | FPD | Class II | |
| K083560 | Expanded Spectrum Photo Therapy Device, Model Espt-3X | Lighthouse Technical Innovations, Inc. | ILY | Class II | |
| K083400 | Custom Comfort Nightguard | Den Tek Oral Care, Inc. | OBR | Unclassified | |
| K083364 | 2.5 Mm Multidirectional Threaded Pegs, Models 131211110-131211130, 1.5 Mm Locking Screws, Models 131220408-131220424 | Depuy Orthopaedics Inc. | HRS | Class II | |
| K083353 | Capsure(r) Ps System | Spine Wave Inc | MNI | Class II | |
| K082914 | Clampfix | Synthes GmbH | NKB | Class II | |
| K082770 | Zimmer Natural Nail System Tibial Nail | Zimmer GmbH | HSB | Class II | |
| K082769 | Mesa and Range Spinal Systems | K2M, Inc | KWP | Class II | |
| K082744 | Beautibond | Shofu Dental Corp. | KLE | Class II | |
| K082671 | Herculite Ultra | Sybron Dental Specialties, Inc. | EBF | Class II | |
| K082559 | Spectranetics Cross-Pilot Turbo Elite Support Catheter | Spectranetics Corp. | DQY | Class II | |
| K082385 | Chaperon Guiding Catheter | Terumo Cardiovascular Systems Corporation | DQY | Class II | |
| K082008 | Bionet Bm3plus Patient Monitor | Bionet Co., Ltd. | MWI | Class II | |
| K081972 | Bioclean Chemo Emerald Powder Free Nitrile Examination Gloves | Nitritex (M) Sdn. Bhd. | LZA | Class I | |
| K081825 | Bd Probetec Neisseria Gonorrhoeae (Gc) Q Amplified DNA Assay | Becton Dickinson & Co | LSL | Class II | |
| K081824 | Bd Probetec Chlamydia Trachomatis (CT) Q Amplified DNA Assay | Becton Dickinson & Co | MKZ | Class I | |
| K070541 | Ivivi Sofpulse, Models 912-M10, Roma3 and Torino II | Ivivi Technologies, Inc. | ILX | Class II | |
| K083308 | Pass Lp Spinal System | Medicrea Technologies | MNI | Class II | |
| K083306 | Modification to Arthrocare Arthrowands | ArthroCare Corporation | GEI | Class II | |
| K083299 | Taidoc Td-11 Series and Clever Td-1112 Ear/skin/ Surface Ir Thermometers & Fora Ir16/17 Ear Thermometer | Taidoc Technology Corporation | FLL | Class II | |
| K082902 | Rz Endoscopic (Minimally Invasive) Instruments and Accessories | RZ Medizintechnik GmbH | GEI | Class II | |
| K082561 | Spectranetics Quick-Cross Extreme Support Catheters | Spectranetics Corp. | DQY | Class II | |
| K082448 | Disposable Vinyl Synthetic Examination Gloves, Powdered | Rich Mountain Medical Products, Inc. | LYZ | Class I | |
| K080810 | Easyra Bilirubin Direct and Total Reagent, Phosphorus Inorganic Reagent and Iron and Magnesium Reagent | Medica Corp. | CIG | Class II | |
| K071526 | Uni-Vent 731 Series Ventilators, Model 731, 731Emv | ZOLL Medical Corporation | CBK | Class II | |
| K071474 | Dimension Clinical Chemistry System Mpo Flex Reagent Cartridge, Calibrator,control, Model Rf425, Rc425,rc426 | Siemens Healthcare Diagnostics Inc. | NTV | Class II | |
| K083472 | Medegen Pressure Rated Extension Sets | Medegen, Inc. | FPA | Class II | |
| K083013 | Pk Diego Powered Dissector Console, Model 7033-9050, Diego Trigger-Enabled Powered Dissector Handpiece, Model 7033-9001 | Gyrus ACMI, Inc. | GEI | Class II | |
| K082922 | Freeway and Railrunner Guidewires | Lake Region Mfg., Inc. | DQX | Class II | |
| K082700 | Temporary Cold.v and Self-Cure Dentine | Major Prodotti Dentari S.p.A. | EBG | Class II | |
| K082672 | Novabone Putty-Bioactive Synthetic Bone Graft | Novabone Products, LLC | MQV | Class II | |
| K082308 | Modification to Vigileo Arterial Pressure Cardiac Output/oximetry Monitor | Edwards Lifesciences LLC | DXG | Class II | |
| K082302 | Powder Free Nitrile Patient Examination Gloves with Chemo Labeling Claim | PT. Medisafe Technologies | LZA | Class I | |
| K082297 | Busse Surgical Drape | Busse Hospital Disposables | KKX | Class II | |
| K081828 | Zoll R Series Bls Defibrillator | ZOLL Medical Corporation | MKJ | Class III | |
| K081645 | Agilis Nxt Steerable Introducer, Model G408324 | Abbott Medical | DYB | Class II | |
| K080428 | Attain Command 6250 Left Heart Delivery Systems and Attain Command 6250 Guide Catheters for Left Heart Delivery | Medtronic, Inc. | DQY | Class II | |
| K080022 | Gel-Sponge ENT, Absorbable Gelatin Sponge, Usp | Vascular Solutions LLC | KHJ | Class II | |
| K073681 | Nanobeam 940, Model 940-900-02 | Davaray, Inc. | ILY | Class II | |
| K071573 | Rugalift, Model# V.2.1 | Fatrotek S.r.l. | NFO | Class II | |
| K082580 | Spectra Guidewire Introducer Needle | Spectra Medical Devices, LLC | DYB | Class II | |
| K082574 | Maxtorque Mini Cannulated Screw System | TORNIER Inc. | HWC | Class II | |
| K082384 | Hav-Lok Bunion Correction System | Instratek, Inc. | HTN | Class II | |
| K080499 | Magstim Double 70Mm Air Film Coil, Model 3910-00 | Magstim Inc. | GWF | Class II | |
| K083293 | Viatronix V3d-Cardiac, Revision 1.0 | Viatronix, Inc. | JAK | Class II |