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 |
|---|---|---|---|---|---|
| K050594 | Nano-Check Dat 5 Multi Drug Screening Test for Cannabinoids, Opiates, Cocaine, Methamphetamine & Phencyclidine | Nano-Ditech Corporation | LDJ | Class II | |
| K051139 | Acuson Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | |
| K051090 | X-Change | Meyra, Inc. | IOR | Class I | |
| K051076 | Zoll Stat*padz Mwp Multi-Function Electrodes | ZOLL Medical Corporation | MKJ | Class III | |
| K051025 | Fluoroscan Insight Mini C-Arm Fluoroscopic Imaging System | Hologic, Inc. | JAA | Class II | |
| K050961 | Rna1c Control for Nycocard Hba1c | Bionostics, Inc. | JJX | Class I | |
| K050788 | Everlife | Everlife Medical Instrument Co., Ltd. | GXY | Class II | |
| K050717 | Proclear Ultravue Toric, Proclear Ultravue Multifocal, Proclear Ultravue 200T Multifocal Toric | CooperVision, Inc. | LPL | Class II | |
| K050680 | Blood Pressure Monitor with Spectrum/p2, X2, A2, and K7 | Ostar Meditech Corp. | DXN | Class II | |
| K050596 | Quantia A1-at | Biokit, S.A. | DEM | Class II | |
| K050469 | Ez-Stik Electrodes | Naimco, Inc. | GXY | Class II | |
| K050130 | Kerberos Proximal Solutions Rispiration System | Kerberos Proximal Solutions, Inc. | QEZ | Class II | |
| K050128 | Vitalware Vms | Televital, Inc. | DRG | Class II | |
| K050093 | Mac-Lab/cardiolab Ep/combolab System | GE Medical Systems Information Technologies, Inc. | DQK | Class II | |
| K051083 | Acumed Scapula Congruent Bone Plate System | Acumed LLC | HRS | Class II | |
| K051081 | Essenpacs | Cymed Engineering, Inc. | LLZ | Class II | |
| K051072 | Bio-Rad Variant Nbs Sickle Cell Program | Bio-Rad Laboratories Inc. | GKA | Class II | |
| K051039 | Basis Spinal System | Medtronic Sofamor Danek USA Inc | KWQ | Class II | |
| K050930 | E.p.t. Certainty Pregnancy Test | Unipath, Ltd. | LCX | Class II | |
| K050881 | Bd Phoenix Automated Microbiology System - Tetracycline (Strep) 0.0625 - 16 Ug/ml | Becton Dickinson & Co | LON | Class II | |
| K050816 | Vitek 2 Gram Positive Meropenem | bioMerieux, Inc. | LON | Class II | |
| K050780 | Bd Phoenixtm Automated Microbiology System - Penicillin (Strep) 0.156 -32 Ug/ml | Becton Dickinson & Co | LON | Class II | |
| K050749 | Arthrex Tak Family | Arthrex GmbH | HWC | Class II | |
| K050715 | Quanta Plex Anca Profile | Inova Diagnostics, Inc. | MOB | Class II | |
| K050660 | Femtex and Private Label Plastic Applicator Tampons | First Quality Hygienic, Inc. | HEB | Class II | |
| K050600 | Miniloc Safety Infusion Set | Specialized Health Products, Intl. | FPA | Class II | |
| K050503 | Single Use Aspiration Needle Na-201Sx-4022 | Olympus Medical Systems Corp. | FCG | Class II | |
| K050471 | 4Cis Solar Spine System and 4Cis Apollon Spine System | Solco Biomedical Corp. | MNH | Class II | |
| K042988 | Rapid One Step Buprenorphine Test Card | Tianjin New Bay Bioresearch Co., Ltd. | DJG | Class II | |
| K042450 | Sterrad Nx Challenge Pack | Advanced Sterilization Products | FRC | Class II | |
| K051100 | Modification to: Microlife Digital Pacifier Thermometer, Model Mt1751q | Microlife Intellectual Property GmbH | FLL | Class II | |
| K050959 | Delton Illuminating Pit and Fissure Sealing | Dentsply International, Inc. | EBC | Class II | |
| K050937 | Trabecular Metal Acetabular Revision Shells | Zimmer Trabecular | LPH | Class II | |
| K050920 | Czr Press Lf Stains | Noritake Co., Inc. | EIH | Class II | |
| K050892 | Hallmarktm Anterior Cervical Plate System | Blackstone Medical, Inc. | KWQ | Class II | |
| K050720 | Neurosensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit/system, Models Ns-P, Ns-100 | Integra NeuroSciences | GWM | Class II | |
| K050556 | Alumina Head | Fournitures Hospitalieres Industrie | LZO | Class II | |
| K050464 | Ultracare Disposable Pen Needles, Models 31 Gauge X3/16, 29 Gauge X 1/2 | Ultimed, Inc. | FMI | Class II | |
| K050252 | Ac-1 Adapter Cable, 8 Pin and 12 Pin Philips | Masimo Corporation | DQA | Class II | |
| K050071 | Medispo (Powdered) and Medispo-Pf (Powder-Free) Surgeons Glove | H.B.M. USA Co.,Inc. | KGO | Class I | |
| K043518 | Radiopaque Bone Cement | Cardinalhealth | NDN | Class II | |
| K043203 | Wilson-Cook Enteral Feeding Tube, Tiger Tube Enteral Feeding Tube | Wilson-Cook Medical Inc. | KNT | Class II | |
| K041984 | Acecide High-Level Disinfectant and Sterilant | Best Sanitizers, Inc. | MED | Class II | |
| K051046 | Painacea Model Xr8 Infrared Heat Lamp | Atlantis Luminescent Products, LLC | ILY | Class II | |
| K050775 | Resscan | ResMed Corp | BZD | Class II | |
| K050029 | Cardiompo Test | Prognostix, Inc. | NTV | Class II | |
| K043466 | Painpump2 | Stryker Corp. | FRN | Class II | |
| K043218 | Abl800 Flex with Flexq Module, Model Abl8xx | Radiometer Medical ApS | CHL | Class II | |
| K042990 | For Sure One Step Buprenorphine Test Strip | Tianjin New Bay Bioresearch Co., Ltd. | DJG | Class II | |
| K042977 | Lasik Eye Drape | Odyssey Medical, Inc. | KKX | Class II |