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 |
|---|---|---|---|---|---|
| K010100 | Avon Patello-Femoral Joint Prosthesis | Howmedica Osteonics Corp | KRR | Class II | |
| K003542 | Preamp Cable, Model B400-1011Pa | Beta Biomed Services, Inc. | DQA | Class II | |
| K003274 | Lpc-Plus Acetabular Cup | Plus Orthopedics | LZO | Class II | |
| K002889 | Pns Magnetic Stimulator System | Neotonus, Inc. | KOI | Class II | |
| K002726 | Tcoyf Fertility Software Version 1.0 | Ovusoft, LLC | LHD | Unclassified | |
| K010912 | Alarmview Wireless Data Network System | Data Critical Corp. | MSX | Class II | |
| K010906 | Medtronic Stylet Kit, Models 6282, 6293, and 6254 | Medtronic, Inc. | DRB | Class II | |
| K010900 | Sts-T Lithotripter, Model Sts-T | Medstone Intl., Inc. | LNS | Class II | |
| K010859 | The Liberator Wheelchair | Liberator Wheelchairs, Inc. | ITI | Class II | |
| K010829 | Powder Free Elastic Vinyl Examination Gloves | General Gloves Corp. | LYZ | Class I | |
| K010664 | Copeland Resurfacing Humeral Heads | Biomet Manufacturing Corp | HSD | Class II | |
| K010655 | At Home Drug Testt, Model 9150 T | Phamatech Inc. | MVO | Unclassified | |
| K010654 | At Home Drug Test, Model 9078 T | Phamatech Inc. | MVO | Unclassified | |
| K010653 | At Home Drug Test, Model 9068 T | Phamatech Inc. | MVO | Unclassified | |
| K010623 | Reconstitution Kit & Vial Connector | Bioject, Inc. | LHI | Class II | |
| K010593 | Surevue Serum/urine Hcg, Model 1,30,50,100 Test Kit | SA Scientific, Ltd | JHI | Class II | |
| K010564 | Verdict -II Thc/coc/opi/amp/pcp/bar/bzo & Thc/coc/bar/bzo; Profile -II 7 Thc/coc/opi/amp/pcp/bar/bzo | MEDTOX Diagnostics, Inc. | DKZ | Class II | |
| K010561 | Verdict -II Bar/bzo | MEDTOX Diagnostics, Inc. | DIS | Class II | |
| K010377 | Mimimed Sil-Serter Infusion Set Insertion System, Model 385 | Minimed, Inc. | KZH | Class II | |
| K010236 | Immage Immunochemistry System High Sensitivity C-Reactive Protein (Crph) Reagent | Siemens Healthcare Diagnostics Inc. | DCK | Class II | |
| K010199 | Pjur Eros Water Formulation | L.C.C. Pjur Group Germany | NUC | Class II | |
| K010196 | Total Cure | Bisco Inc | EBF | Class II | |
| K010133 | Versalux | Centrix, Inc. | EBZ | Class II | |
| K010129 | Excelart with Pianissimo, Model Mrt-1500/P3 | Toshiba America Medical Systems, In.C | LNI | Class II | |
| K010046 | Nuvolase 532 Medical Laser System | American Laser Corp. | GEX | Class II | |
| K003701 | Sentech Medical Express Compression System (P/n Sm800) | Sentech Medical Systems, Inc. | JOW | Class II | |
| K003350 | Health-Plus, Sanitex, Reliance Multiply Powder Free Polymer and Nitrile Coated (Blue) | Pamitex Industries Sdn Bhd | LYY | Class I | |
| K002892 | Frsenius Pd Iqcard Cycler | Fresenius Medical Care Renal Therapies Group, LLC | FKX | Class II | |
| K002617 | Periform Perineometric Probe, Model 8300 | Neen Design, Ltd. | HIR | Class II | |
| K994083 | Stannah Power Chair, Model 201 | Stannah Power Chairs, Ltd. | IPL | Class II | |
| K010737 | Select Cap Arterial Cannula with Pressure Monitoring Line, Model 78818,78820,78822,78824,78918,78920,78922,78924 | Medtronic Cardiac Surgical Products | DWF | Class II | |
| K010117 | Guidant Axius Coronary Shunt | Cardiothoracic Systems, Inc. | DXC | Class II | |
| K010035 | Ivs Tunneller | United States Surgical, A Division of Tyco Healthc | FTL | Class II | |
| K003417 | Mini Fiber Endoscopes; Outer Sheaths; Veress Cannulas; Veress Cannulas with Outer Sheaths, Set | Richard Wolf Medical Instruments Corp. | HET | Class II | |
| K003272 | Flo-Boot | Discovery Group, LLC | BXB | Class I | |
| K010861 | Laglove Brand Colored Powdered Nitrile Examination Gloves(green/purple) | La Glove (M) Sdn. Bhd. | LZA | Class I | |
| K010860 | Laglove Brand Colored Powder Free Nitrile Examination Gloves (Green/purple) | La Glove (M) Sdn. Bhd. | LZA | Class I | |
| K010792 | Mammograph | Digitec Medical Service Corp. | IZH | Class II | |
| K010558 | Quanta Lite Gpa (Gastric Parietal Cell Antibody) Elisa | Inova Diagnostics, Inc. | MLE | Class II | |
| K010461 | Advia Retic Plus | R & D Systems, Inc. | JPK | Class II | |
| K010271 | Thinkingnet | Thinking Systems Corp. | LLZ | Class II | |
| K010110 | Powder-Free Nitrile Examination Gloves, White | Shen Wei (USA), Inc. | LZA | Class I | |
| K010074 | Model 455Ge Phased Array Wrist Coil | Medical Advances, Inc. | MOS | Class II | |
| K003986 | Ultrasound Scanner Type 2102 | BK Medical ApS | IYN | Class II | |
| K003613 | 3.0.T Signa Vh/i (T/r) Body Imaging Coil | GE Healthcare | MOS | Class II | |
| K001892 | White Knight Masks (21 Models, Various Colors with and without Face Shields) | White Knight Healthcare | FXX | Class II | |
| K010762 | Philips Bv Libra | Philips North America LLC | OXO | Class II | |
| K010685 | Modification to Miller/galante Precoat Unicompartmental Knee System (8 Mm Articular Surface) | Zimmer GmbH | HSX | Class II | |
| K010412 | Flexible Endoscopic Scissors | TeleMed Systems | OCZ | Class II | |
| K010192 | Endoscopic Tube Shaft Instruments for Monoplar Coagulation | Antyllos Medizintechnik GmbH | GEI | Class II |