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 |
|---|---|---|---|---|---|
| K990537 | Osteo-Pin Membrane Fixation Pin | Luitpold Pharmaceuticals, Inc. | LYC | Class II | |
| K990292 | I/a (Irrigation/aspiration) Pack, Posterior Vitrecomy Pack, Anterior Virectomy Pack, Phacoemulsification Pack, Admiinisn | Ophthalmic Consultants, Inc. | HQE | Class II | |
| K993581 | Haemonetics Ln 193 Disposable Set, for Use with the Haemonetics Cellsever Haemolite 2 Family of Autologous Blood Recover | Haemonetics Corporation | CAC | Class II | |
| K993285 | Aurora Sl | Premier Laser Systems, Inc. | GEX | Class II | |
| K993160 | Omega Trac, Model Z100 | Teftec Corp. | ITI | Class II | |
| K992950 | Custom Prosthetic (Hefilcon a) Soft Lens | Prosthetic Soft Lens Corp. | LPL | Class II | |
| K992945 | Rci Fixation Screws (with Assorted Sizes) | Smith & Nephew, Inc. | HWC | Class II | |
| K992915 | One-Step Double-Chek Pregnancy Test | Biomedical Products Corp. | JHI | Class II | |
| K992874 | Q-Sweat Quantitative Sweat Measurement System | WR Medical Electronics Co. | KTB | Class II | |
| K992866 | Optilite IX Laser Surgery Accessories | Convergent Laser Technologies | GEX | Class II | |
| K992813 | 11 Gauge Probe, Stereotactic, 14 Gauge Probe, Stereotactic,14 Gauge Probe, Ultrasound, Housing Stereotactic,housing, Ult | Ethicon Endo-Surgery Inc | KNW | Class II | |
| K992697 | Port-a-Cath II Trans-Arterial Percutaneous System | Sims Deltec, Inc. | LJT | Class II | |
| K992510 | Wallstent Tracheobronchial Endoprosthesis and Unistep Plus Delivery System | Boston Scientific Corporation | JCT | Class II | |
| K991786 | Mars Unity Workstation with Heart Rate Variability (Hrv) Option | General Electric Medical Systems Information Techn | DPS | Class II | |
| K991286 | Avocet Acusure System | Avocet Medical, Inc. | GJS | Class II | |
| K990475 | Trapis (Transperineal Prostate Implant Simulator), Version 1.5 | Kps & Assoc., Inc. | MUJ | Class II | |
| K990290 | Craniofacial Calcium Phosphate Ceramic Bone Filler | Zimmer GmbH | GXP | Class II | |
| K990177 | Nellcor Puritan Bennett Achieva Ventilator and Report Generator | Medtronic, Inc. | CBK | Class II | |
| K984219 | Colormax Color Vision Enhancement Lenses | Color Vision Technologies, Inc. | NAI | Class I | |
| K983753 | Star Temporary Wound Cover | Osteogenics, Inc. | FTL | Class II | |
| K983239 | Water Purification Components and Systems Hemodialysis | Rasco | FIP | Class II | |
| K993669 | Lipoprotein (a) Spq III Antibody Reagent Set | Diasorin Inc. | DFC | Class II | |
| K993588 | Modification to Rx Herculink 14 Biliary Stent System, Models 1005126-13, 1005128-13, 1005130-13, 1005132-13, 1005134-13, | Boston Scientific Corporation | FGE | Class II | |
| K993326 | Non-Sterile Polymer Coated Powder Free Latex Examination Gloves with a Protein Labeling Claim (70 Micrograms or Less per | Seal Polymer Industries Bhd. | LYY | Class I | |
| K993251 | Immulite 2000 Vitamin B12, Model L2kvb2, L2kvb6 | Siemens Healthcare Diagnostics Inc. | LIG | Class II | |
| K993134 | Cashmere Non-Sterile Blue Powdered Nitrile Examination Glovesblue and Green) | Seal Polymer Industries Bhd. | LZA | Class I | |
| K993133 | Cashmere Non-Sterile Powdered Nitrile Examination Gloves Blue and Green | Seal Polymer Industries Bhd. | LZA | Class I | |
| K993120 | Modified Blood Recipient Set | Baxter Healthcare Corporation | BRZ | Class II | |
| K992931 | Non-Stick Bipolar Forceps | Silverglide Surgical Technologies | GEI | Class II | |
| K992824 | Laserex Nd:yag Ophthalmic Laser (Lq2106), Alcon Nd:yag Ophthalmic Laser (3000Le), Laserex Nd:yag Ophthalmic Laser, Model | Ellex Medical Pty Ltd | GEX | Class II | |
| K992822 | Seal & Protect Protective Sealant for Exposed Dentine | Dentsply Intl. | LBH | Class II | |
| K992678 | Patient Nitrile Examination Gloves Powder Free Chlorinated | Wear Safe (Malaysia) Sdn Bhd | LZA | Class I | |
| K991993 | Phacolase Er: Yag Laser | Aesculap-Meditec GmbH | GEX | Class II | |
| K990779 | Hemaseal & Cide | Advantage Dental Products, Inc. | LBH | Class II | |
| K993715 | Qualitrol Cardiac Marker Control, Levels, 1,2 and 3 | Seracare Technology | JJT | Class I | |
| K993670 | Modified Long Length Gamma Nail | Howmedica Osteonics Corp | HSB | Class II | |
| K993647 | Unimed Disposable Hand and Foot-Switching Pencils with Holster and 1Blade and Tip Cleaner, Unimed Disposable Hand and F | Unimed Surgical Products, Inc. | GEI | Class II | |
| K993640 | Spectrum Libre Wheelchair | Freedom Designs Inc | IOR | Class I | |
| K993601 | Howmedica Osteonics Femoral Heads | Howmedica Osteonics Corp | LWJ | Class II | |
| K993510 | Modified Bmp Trochanteric Plates | Zimmer GmbH | HRS | Class II | |
| K993298 | E Z Chair | Premier Designs | IOR | Class I | |
| K993177 | Sabre | Sle Limited | GWJ | Class II | |
| K993067 | Silhouette Spinal Fixation System | Zimmer Spine, Inc. | KWP | Class II | |
| K992993 | Etest for Quinupristin/dalfopristin | Ab Biodisk | LTX | Class II | |
| K992978 | Ricrokeratome Blade | Surgistar, Inc. | HNO | Class I | |
| K992793 | Sodium Bicarbonate Mixing/delivery System, and the Concentrate Delivery System | Better Water, Inc. | FIN | Class II | |
| K992792 | Xia Spinal System C-C Adaptor | Howmedica Osteonics Corp | KWQ | Class II | |
| K992776 | Uni-Graft K Dv Patch | Atrium Medical Corporation | DXZ | Class II | |
| K992287 | First Step Unicompartmental Knee System | Howmedica Osteonics Corp | HSX | Class II | |
| K991059 | Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics 0.018 Support Catheter, Model 518-017 | Spectranetics Corp. | DQY | Class II |