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 |
|---|---|---|---|---|---|
| K070755 | Interworks | Avreo, Inc. | LLZ | Class II | |
| K070529 | Aff (Mark I) Volumetric Infusion Pump | Definitive Medical Technologies, Ltd. | FRN | Class II | |
| K070441 | Metasurg Subtalar Implant | Metasurg | HWC | Class II | |
| K070328 | BIPAP Synchrony with Avaps | Respironics Inc., Sleep & Home Respiratory Group | MNS | Class II | |
| K063742 | Resonance Metallic Ureteral Stent | Cook Ireland Ltd. | FAD | Class II | |
| DEN060009 | 3M N95 Home Respirator with Fluid Resistance; 3M N95 Home Respirator | 3M Company | NZJ | Class II | |
| K070823 | Growth Control Plating System | Biomet Trauma | HRS | Class II | |
| K070740 | Chad Therapeutics Bonsai Model 800 | Chad Therapeutics, Inc. | NFB | Class II | |
| K070715 | Nasopore Ear | Polyganics B.V. | NHB | Class II | |
| K070642 | Aeroneb Professional Nebulizer System | Aerogen (Ireland), Ltd. | CAF | Class II | |
| K070612 | Top-Rank Adhesive Electrode | Top-Rank Health Care Equipment Co., Ltd. | GXY | Class II | |
| K070593 | Trackrecord Data Management Software | Home Diagnostics, Inc. | NBW | Class II | |
| K070475 | Modificaton to: Given Diagnostic Imaging System | Given Imaging Ltd. | NEZ | Class II | |
| K070452 | Variant II Hemoglobin A1c Program with Models 270-2101Nu | Bio-Rad Laboratories Inc. | LCP | Class II | |
| K070362 | Surflo Winged Infusion Set | Terumo Europe N.V. | FPA | Class II | |
| K070068 | Nova Statsensor Creatinine Hospital Meter, Control Solutions,linearity Solutions, and Test Strips | Nova Biomedical Corporation | CGL | Class II | |
| K063802 | Lenstec Lc Injection System | Lenstec, Inc. | MSS | Class I | |
| K063545 | Multi-Drug of Abuse Urine Test,urine Cup Test, Amphetamine Urine Test(cassette, Dip-Strip), Cocaine, Methamphetamine | Alfa Scientific Designs, Inc. | DJG | Class II | |
| K063363 | Firmgrip Peripherally Inserted Catheter Device | Flexicath, Ltd. | LJS | Class II | |
| K062096 | Koreamedico Chextic Hcg Urine Pregnancy Test | Koreamedico Co., Ltd. | LCX | Class II | |
| K070326 | Noga Automated Sleep Study Scoring and Data Management System | Widemed, Ltd. | MNR | Class II | |
| K071065 | Orthadapt Bioimplant | Pegasus Biologics, Inc. | FTM | Class II | |
| K070963 | Reunion Ha Fracture Stem | Howmedica Osteonics Corp | HSD | Class II | |
| K070741 | Cliniqa Liquid Qc Unassayed and Assayed General Chemistry Control Levels 1, 2, & 3 | Cliniqa Corporation | JJY | Class I | |
| K070681 | Next Generation Anterior Cervical Plating System | Alphatec Spine, Inc. | KWQ | Class II | |
| K070626 | Synchron Systems High Sensitivity Cardiac C-Reactive Protein (Crph) Reagent | Siemens Healthcare Diagnostics Inc. | NQD | Class II | |
| K070615 | Angiodynamics, Inc., Morpheus CT Picc and Procedure Kit | Boston Scientific Corporation | LJS | Class II | |
| K070614 | Corscreen | Viasys Healthcare GmbH | DPS | Class II | |
| K070609 | Apex Medical Xt1 CPAP, Model 9S-005 | Apex Medical, Inc. | BZD | Class II | |
| K070527 | Arcuate Vertebral Augmentation System | Medtronic Sofamor Danek | NDN | Class II | |
| K070399 | 100Kgy E-Poly Acetabular Liners-Additional Profiles | Biomet Manufacturing Corp | JDI | Class II | |
| K070393 | Lagwire System | Fxdevices | HWC | Class II | |
| K070368 | Trio Plate System, Trio Spinal Fixation System, Trio+ Spinal System | Stryker Corp. | NKB | Class II | |
| K070331 | Urostym Biofeedback and Stimulation Device and Accessories | Abbott Medical | KPI | Class II | |
| K070289 | Acquaseal Benz | Acquamed Technologies, Inc. | LBH | Class II | |
| K070240 | Carto Xp Ep Navigation System, Version 9 | Biosense Webster Inc | DQK | Class II | |
| K070054 | First Response Gold Digital Pregnancy Test | Church & Dwight Co., Inc. | LCX | Class II | |
| K063752 | Lifesense, Model Ls1-9R | Nonin Medical, Inc | DQA | Class II | |
| K062784 | Sejoy Digital Thermometer, Mt Series (Mt-201, Mt-301, Mt-402, Mt-403 and Mt-405) | Sejoy Electronics & Instruments Co., Ltd. | FLL | Class II | |
| K061257 | Dbest Hcg Panel Test Kit | Ameritek USA, Inc. | JHI | Class II | |
| K071055 | Opal Prime & Opal Bond/orthodontic Bracket System, Models 2626, 2625, 2635, 2803, 2802 | Ultradent Products Inc. | DYW | Class II | |
| K070364 | 100Kgy E-Poly Maxrom Acetabular Liners | Zimmer GmbH | JDI | Class II | |
| K070324 | Ipc-Boot | C-Boot, Ltd. | JOW | Class II | |
| K070229 | Range Spinal System | K2M, Inc | MNI | Class II | |
| K070120 | Autovent Model 4000 | Allied Medical LLC | BTL | Class II | |
| K063319 | Monolisa Anti-Hav Igm Eia | Bio-Rad Laboratories Inc. | LOL | Class II | |
| K063318 | Monolisa Anti-Hav Eia | Bio-Rad Laboratories Inc. | LOL | Class II | |
| K071017 | Immulite 2500 High Sensitivity C-Reactive Protein, Models L5kcrp (200 Tests), L5kcrp (600 Tests) | Siemens Healthcare Diagnostics Inc. | NQD | Class II | |
| K070982 | Cts-7700 Digital Ultrasound Imaging System | Shantou Institute of Ultrasonic Instuments | IYO | Class II | |
| K070925 | Modification to: Bioknotless Br Anchor / Lupine Br Anchor | DePuy Mitek, Inc. | MAI | Class II |