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 |
|---|---|---|---|---|---|
| K965002 | Zirconia Ceramic Femoral Heads with Foundation Forged, Textured and Porous Stems, the Encore Vitality Stems and Sl and | Encore Orthopedics, Inc. | LZO | Class II | |
| K964131 | Endoscope | Akos Biomedical, Inc. | FAM | Class II | |
| K963160 | Hx-5/6-1 Endoscopic Clipping Device | OLYMPUS Corporation of the Americas | PKL | Class II | |
| K972246 | Spectacle Frames (Non-Prescription) | Alimar Trading, Inc. | HQY | Class I | |
| K972136 | Tv Monitor (P12/17) | Perkins Mfg. Co. | IZI | Class II | |
| K972077 | Epi-Stop Epistaxis Catheter | Boston Medical Products, Inc. | EMX | Class I | |
| K972076 | Epi-Max Epistaxis Catheter | Boston Medical Products, Inc. | EMX | Class I | |
| K972070 | Nichols Advantage Chemiluminescence Tri-Level Specialty Controls | Nichols Institute Diagnostics | JJY | Class I | |
| K971995 | Medivision Sinoscope | Medivision Scope Service Center, Inc. | EOB | Class II | |
| K971899 | Endo-Seal | Ultradent Products Inc. | KIF | Class II | |
| K971491 | Synermed Ir 200 Chemistry Analyzer | Synermed, Inc. | JJF | Class I | |
| K971451 | Wise Image Management System | O Tech, Inc. | LMB | Class I | |
| K971368 | Ids4 Image Display System Series | O Tech, Inc. | LLZ | Class II | |
| K971167 | Neoprobe Model 1500 Portable Radioisotope Detector and Accessories | Neoprobe Corp. | IZD | Class I | |
| K970543 | Bobcat Dx | Quest Enabling Designs, Ltd. | IPL | Class II | |
| K970395 | Quikstrip One Step Methamphetamine | Drial Consultants, Inc. | DKZ | Class II | |
| K970269 | Clinicath Ir Peripherally Inserted Catheter | Sims Deltec, Inc. | LJS | Class II | |
| K970012 | Escort Link Central Station Monitor | Medical Data Electronics | DSI | Class II | |
| K964969 | Signa Sp Crown Coils (Numbers 1 Through 3) | GE Healthcare | MOS | Class II | |
| K964728 | Sta-Liatest D-Di Test Kit | American Bioproducts Co. | DAP | Class II | |
| K964716 | Sta Liatest Control [N]+[p] Kit | American Bioproducts Co. | GGN | Class II | |
| K964673 | Bair Hugger Model 630 Cardiac Blanket | Augustine Medical, Inc. | DWJ | Class II | |
| K964606 | Theratron 780E | Theratronics, Inc. | IWB | Class II | |
| K963732 | Percutaneous Dual Cannula Tracheostomy Tube with Low Pressure/low Profile Cuff and Disposable Inner Cannula | Mallinckrodt Medical | JOH | Class II | |
| K971841 | Bionike Aq One Step Cannabinoids (Thc) Test | Bionike Laboratories, Inc. | LDJ | Class II | |
| K971679 | I-Scope Ophthalmic Endoscope | Ophthalmic Technologies, Inc. | MPA | Class II | |
| K971600 | Emit Calibrator B Level 1 (Cutoff)/emit Calibrator B Level 2 (High) | Behring Diagnostics, Inc. | DKB | Class II | |
| K971596 | Emit II Opiates 300/2000 Assay | Behring Diagnostics, Inc. | DJG | Class II | |
| K971541 | Vaginal 2 Electrode Stimulation/emg Probe - Tampon | Hollister, Inc. | KPI | Class II | |
| K971331 | Satellite | Nicolet Biomedical, Inc. | GWQ | Class II | |
| K971154 | Multipics(me-977) | Merlin Engineering Works, Inc. | LMD | Class I | |
| K971153 | Splitscreen (Me-975) | Merlin Engineering Works, Inc. | LMD | Class I | |
| K971144 | Multitak Ss Suture System | Bonutti Research, Inc. | MBI | Class II | |
| K971139 | Bone Anchor System for Soft Tissue Support | Boston Scientific Corporation | MBI | Class II | |
| K970879 | Cardiovit Cs-200 | Schiller America, Inc. | LOS | ||
| K970285 | Aesuclap Socon Spinal System | Aesculap Inc | MNH | Class II | |
| K964923 | Codman Lumbar Drainage Catheter Kit | Johnson & Johnson Professionals, Inc. | JXG | Class II | |
| K964757 | Contidrain Catheter | Contimed, Inc. | EZL | Class II | |
| K963074 | Harmac Quadpolar Mapping Pacing Catheter | Harmac Medical Products | DRF | Class II | |
| K943535 | Model Me 300 Muscle Tester | Regulatory Strategies, Inc. | HCC | Class II | |
| K972232 | Abbott Axsym Folate | Abbott Medical | CGN | Class II | |
| K972214 | Roche Serum Control Normal (Human), Roche Serum Control Pathological (Human) | Roche Diagnostic Systems, Inc. | JJY | Class I | |
| K972194 | Riviera Sunglass4es | Riviera Optical Co., Ltd. | HQY | Class I | |
| K972174 | Lyphochek Remedi Control | Bio-Rad | DIF | Class I | |
| K972133 | Vitros Immunodiagnostics Products Progesterone Reagent Pack (Gem.1070), Progesterone Calibrators (Gem.c070) | Johnson & Johnson Clinical Diagnostics, Inc. | JLS | Class I | |
| K972073 | Total Bilirubin Reagent | Carolina Liquid Chemistries | CIG | Class II | |
| K972047 | Kls-Martin Rigid External Distraction Device | KLS-Martin L.P. | MQN | Class II | |
| K972014 | Sunglasses (Non-Prescription) | Tamfort, Ltd. | HQY | Class I | |
| K971987 | Synthes (USA) [Synthes] Mini External Fixator | Synthes (USA) Products LLC | JEY | Class II | |
| K971921 | Prolactin (Prl) Hormone Microplate Elisa | Monobind, Inc. | CFT | Class I |