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 |
|---|---|---|---|---|---|
| K042153 | South Beach Smile Light Whitening System | Dentovations, Inc. | EEG | Class I | |
| K041959 | Polaris Ds/comet | Syneron Medical, Ltd. | GEX | Class II | |
| K041392 | Sonx 35 Ultrasonic Bleaching System; Soniwhite Ultra Sonic, Model Quick White US | Cao Group, Inc. | EEG | Class I | |
| K041239 | Genesis Medical Technologies, Inc. Pharmajet Needle-Free Injector, Model M2000 | Genesis Medical Technology, Inc. | KZE | Class II | |
| K042900 | K.e.p. Connector and Clip | K.E.P., LLC | KDJ | Class II | |
| K042874 | Angiojet Xmi Catheter - Rapid Exchange (Xmi-Rx) | Possis Medical, Inc. | QEZ | Class II | |
| K042836 | Liquichek Reticulocyte Control (a) | Bio-Rad | JPK | Class II | |
| K042815 | Quest Tumor Marker Control, Model 955 | Bio-Rad | JJY | Class I | |
| K042796 | Endotine Transbleph 3.0/3.5 Device | Coapt Systems, Inc. | HWC | Class II | |
| K042717 | Mas, Dade and Liquid Assayed Diabetes Control | Medical Analysis Systems, Inc. | JJX | Class I | |
| K042619 | Ultrabio - in Vivo Biocompatible, Bioeliminated Sterile Ultrasound Imaging Couplant | Sonotech, Inc. | MUI | Class II | |
| K042617 | 31P/1h Headcoil for Magnetom Allegra | Siemens Medical Solutions USA, Inc. | MOS | Class II | |
| K042615 | Carbon Medical Technologies Endoscopic Injection Needle | Carbon Medical Technologies, Inc. | FBK | Class II | |
| K042572 | Kendall Co2nfirm Now CO2 Detector | Kendall | KNT | Class II | |
| K042230 | Polarcath Peripheral Balloon Catheter System | Cryo Vascular Systems, Inc. | DQY | Class II | |
| K041891 | Minineph Human Rheumatoid Factor Kit | The Binding Site | DHR | Class II | |
| K041464 | Busse Hospital Disposables Urethral Catheter | Busse Hospital Disposables | EZD | Class II | |
| K041367 | Topcon Model Trc-Nw200 Non-Mydriatic Retinal Camera | Topcon Corp. | HKI | Class II | |
| K041143 | Randox Barbiturate Assay | Randox Laboratories, Limited | DIS | Class II | |
| K040684 | T-Stat Microvascular Tissue Oximeter, Model 303 | Spectros Corporation | MUD | Class II | |
| K042905 | Neo-Clip Orthodontic Bracket Accessory | Dentsply Intl. | NJM | Class II | |
| K042798 | C-Tek C-Trun Anterior Cervical Plate System | Interpore Cross Intl. | KWQ | Class II | |
| K042790 | Cd Horizon Spinal System | Medtronic Sofamor Danek | NKB | Class II | |
| K042778 | Bioanchor with Disposable Driver, Preloaded with One #2 Herculine Suture | Linvatec Corporation | HWC | Class II | |
| K042776 | Versys Hip System Beaded Midcoat Low Head Center Hip Prosthesis, Model 00-7840-Xxx-Xx | Zimmer GmbH | LPH | Class II | |
| K042775 | Inquiry Afocus, Inquiry Afocus II and Inquiry Optima Steerable Electrophysiology Catheter | Irvine Biomedical. Inc. | DRF | Class II | |
| K042652 | Taiwan King Strong Tc 04 Mechanicalwheelchair | Taiwan King Strong Co., Ltd. | IOR | Class I | |
| K042337 | Zimmer M/l Taper Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer GmbH | LPH | Class II | |
| K042210 | Msd Silo Spinal System | Medtronic Sofamor Danek | MNI | Class II | |
| K042120 | Powdered Vinyl Patient Examination Gloves | Shijiazhuang Manful Light Industrial Products Co. | LYZ | Class I | |
| K041356 | Arthrex Tenodesis Screw Family | Arthrex GmbH | HWC | Class II | |
| K041189 | Arthrex Trimit Family | Arthrex GmbH | HWC | Class II | |
| K040354 | Metal/metal Hip System | Encore Medical, LP | KWA | Class III | |
| DEN040009 | Hamilton Thorne Zona Infrared Laser Optical System (Zilos Tk) | Hamilton Thorne Biosciences | MRX | Class II | |
| K042948 | I Open 0.36 T-Magnetic Resonance Imaging System | Wandong Medical | LNH | Class II | |
| K042880 | Jetstream Workspace | Philips North America LLC | KPS | Class II | |
| K042844 | Ge Signa Excite 1.5T 6 Channel Phased Array Flex Coil, Ge Signa Excite 3.0T 6 Channel Phased Array Flex Coil | GE Healthcare | MOS | Class II | |
| K042739 | Hi-Art System | Accuray Incorporated | MUJ | Class II | |
| K042642 | Aware Transport Monitor System (Includes Aware Pod and Aware Transport Monitor) | GE Medical Systems Information Technologies, Inc. | MHX | Class II | |
| K042586 | Best Breast Brachytherapy Applicator | Best Medical International, Inc. | JAQ | Class II | |
| K042434 | Micro-Motorsystems Md20, Sem2, Highsurg 20 & Dt55 | Nouvag AG | DZI | Class II | |
| K042350 | Tes-1 Constant Voltage Electrical Stimulator | Cadwell Laboratories, Inc. | GWF | Class II | |
| K042307 | Architect T-Uptake Calibrators (a-F) and Controls (Low, High) | Seradyn, Inc. | JIT | Class II | |
| K042176 | Aquify Lens Comfort Drops | Alcon Laboratories | LPN | Class II | |
| K042119 | Powder-Free Vinyl Patient Examintion Gloves | Shijiazhuang Manful Light Industrial Products Co. | LYZ | Class I | |
| K041968 | Genicon Bipolar Forceps Model # 600-005-005 | Genicon, Inc. | GEI | Class II | |
| K041712 | 'Rapidtec 4' Test | American Bio Medica Corp. | DIS | Class II | |
| K041144 | Randox Opiates Assay | Randox Laboratories, Limited | DJG | Class II | |
| K042867 | Philips Orthopaedic Applications | Philips North America LLC | LLZ | Class II | |
| K042866 | Amx5 and Amx5d Mobile X-Ray Systems | GE Healthcare Technologies | IZL | Class II |