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 |
|---|---|---|---|---|---|
| K023466 | Tulip Alginate Impression Material | Cavex Holland B.V. | ELW | Class II | |
| K023415 | Modification to Dynalok Classic Spinal System | Medtronic Sofamor Danek | KWP | Class II | |
| K023403 | Spermgrad, Models 10022/10063 | Vitrolife Sweden AB | MQL | Class II | |
| K023384 | Coopersurgical Trial Transfer Catheter | CooperSurgical, Inc. | MQF | Class II | |
| K023383 | Coopersurgical Intrauterine Insemination Catheter | CooperSurgical, Inc. | MQF | Class II | |
| K023292 | Apex Hri Digital Radiography System | Krugman Technologies, Inc. | MUH | Class II | |
| K023261 | Adapt Balloon Open Access Port, Model 41244 | Taut, Inc. | GCJ | Class II | |
| K023243 | Modification to Protege Self-Expanding Nitinol Stent with Starport Delivery Technology | Sulzer Intratherapeutics, Inc. | FGE | Class II | |
| K023233 | Ebi Targetcath Fluoro-Guided Steerable Catheter System | Ebi, LLC | BSO | Class II | |
| K023229 | S.o.f.t. Paddle (Special Optimized Full Compression Tray), Model Sft-Pdle | American Mammographics, Inc. | IZH | Class II | |
| K023212 | Ag Garments Conductive Electrodes, Models 100-104 Sleeves,110-114 Gloves,120-124 Socks,130-132 Panels | Ag Garments | GXY | Class II | |
| K023176 | Undus Male Latex Condom (with Flavoring) | Unidus Corp. | HIS | Class II | |
| K023175 | Unidus Male Latex Condom (with Color and Flavoring) | Unidus Corp. | HIS | Class II | |
| K023129 | Unidus Male Latex Condom (Yellow, Pink, Green & Black) | Unidus Corp. | HIS | Class II | |
| K023063 | Comprehensive Humeral Fracture System | Biomet Orthopedics, Inc. | KWT | Class II | |
| K023017 | Tucker Embryo Catheter | Fertility Technology Resources, Inc. | MQF | Class II | |
| K022905 | Lifejet F16 Hemodialysis/apheresis Chronic Catheter | Boston Scientific Corporation | MSD | Class II | |
| K022773 | Barco Medis 2Mp1nt Medical Diagnostic Display System | Barco N.V. | LLZ | Class II | |
| K022732 | Infant/child Reduced Energy Electrodes | Physio Control, Inc. | MKJ | Class III | |
| K022661 | A1cnow for Home Use | Metrika, Inc. | LCP | Class II | |
| K021643 | Ha Orbital Implant | Laboratoire Villanova | HPZ | Class II | |
| K020899 | Parapac 200 Medic, Model P200, & Parapac 200D Medic, Model P200d | Pneupac, Ltd. | BTL | Class II | |
| K024030 | Millennium Series Manual Wheelchairs | Evermed, Inc. | IOR | Class I | |
| K023957 | Sonosite Hand-Carried Ultrasound System (C2 Series) | FUJIFILM SonoSite,Inc. | IYN | Class II | |
| K023886 | Erbe Vio Esu with Accessories, Model Vio 300 D | Erbe USA Inc | GEI | Class II | |
| K023770 | K2 Hemi Toe Implant System (Formerly Zobel Great Toe Implant System) | Kinetikos Medical, Inc. | KWD | Class II | |
| K023328 | Reinforced Absorbable Synthetic Surgical Mesh | Center for Biomaterials and Advanced Technologies | FTL | Class II | |
| K023317 | Methadone Enzyme Immunoassay | Lin-Zhi International Inc | DJR | Class II | |
| K023180 | Vanguard Reprocessed Diagnostic Electrophysiology Catheters | Stryker Sustainability Solutions | NLH | Class II | |
| K023147 | Analog Multiplexed Cable Telemetry (Amt) Electromyograph, Models Amt-16, Amt-8 & Amt-4 | Bortec Biomedical, Ltd. | IKN | Class II | |
| K023059 | Unidus Male Latex Condom | Unidus Corp. | HIS | Class II | |
| K023051 | Intrauterine Delivery System - Injector | Prosurg, Inc | LKF | Class II | |
| K021726 | Gebauer's Instant Ice | Gebauer Co | MLY | Unclassified | |
| K021682 | Omron Automatic Blood Pressure Monitor with Intellisense, Models Hem-773, Hem-773Ac | Omron Healthcare Co., Ltd. | DXN | Class II | |
| K013562 | Aurora System 1000 Series Home Self-Care Single Patient Delivery System; Models- Sys 1000, L3 with N100 Arm, 4B Software | Baxter Healthcare Corporation | KDI | Class II | |
| K023932 | Ge Photon Energy Recovery (per) Option | GE Medical Systems F.I. Haifa | KPS | Class II | |
| K023928 | Mas Ua Control Liquid Assayed Urinalysis Control, Dade Assayed Urinalysis Control | Medical Analysis Systems, Inc. | JJW | Class I | |
| K023923 | Senocor 360 Circumferential Vacuum Assisted Biopsy Device, 8 Gauge | Senorx, Inc. | KNW | Class II | |
| K023880 | Cardio Vations Steerable Coronary Sinus Catheter | Ethicon, Inc | DWF | Class II | |
| K023803 | Modification to Biotronik's Sterilization Process | BIOTRONIK AG | DTB | Class III | |
| K023777 | Arthronet Blackline 2 and 3 Piece Arthroscopic Blades, Models 123, 133, 153, 163, 173 and 183 | Arthronet Medical, Inc. | HRX | Class II | |
| K023597 | Access Ov Monitor Immunoenzymetric Assay | Siemens Healthcare Diagnostics Inc. | LTK | Class II | |
| K023395 | Portadur P2 | Wieland Dental + Technik GmbH & Co. KG | EJT | Class II | |
| K023379 | Coopersurgical Embryo Transfer Catheter, Coopersurgical Assisted Reproduction Catheter | CooperSurgical, Inc. | MQF | Class II | |
| K023330 | Bilirubin-Sl (Total) Assay, Model 284-10/30 | Sekisui Diagnostics P.E.I. Inc. | CIG | Class II | |
| K023299 | Alpha Mirage Top Tightening Spinal System | Alphatec Spine, Inc. | MNI | Class II | |
| K023267 | T2 Supracondylar Nail System | Howmedica Osteonics Corp | HSB | Class II | |
| K023232 | Splatrfree Swangle 360 Disposable Prophylaxis Angle | Smartpractice | EFS | Class I | |
| K023188 | Press-Fit Head Resurfacing Device | Biomet Orthopedics, Inc. | KXA | Class II | |
| K023041 | W.o.m. Laser U100 | Novanta Medical GmbH | GEX | Class II |