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 |
|---|---|---|---|---|---|
| K052145 | Datex-Ohmeda S/5 Bis Module, E-Bis and Accessories | GE Healthcare | OLW | Class II | |
| K051862 | Pc Compatible Blood Pressure Monitor, Model Ak-4000Tu, Bp-410U, Bp-410R; Automatic Digital Wrist Blood Press. Monitor. | Ya Horng Electronic Co., Ltd. | DXN | Class II | |
| K051785 | Formula 418 Biliary Stent | Cook Inc. | FGE | Class II | |
| K051666 | Gav - General Anaesthetic Vaporizer | General Anaesthetic Services Limited | CAD | Class II | |
| K051567 | Aptus Titanium Osteosynthesis System | Medartis AG | HRS | Class II | |
| K051376 | Accuchek Instant Plus Dual Testing System, Accuchek Instant Plus Cholesterol, Accuchek Instant Plus Glucocose | Roche Diagnostics GmbH | CHH | Class I | |
| K050906 | Vitalcare i.v. Administration Set | Vitalcare Group, Inc. | FPA | Class II | |
| K052246 | Modification to En-Bloc Biopsy System | Neothermia Corp. | GEI | Class II | |
| K052187 | Modification to: Cd Horizon Spinal System | Medtronic Sofamor Danek | NKB | Class II | |
| K052065 | Alliance Medical Corporation Reprocessed External Fixation Devices | Alliance Medical Corp. | KTT | Class II | |
| K052058 | Modification to: Titanium Telegraph Humeral Nail | Fournitures Hospitalieres Industrie | HSB | Class II | |
| K052002 | Iron Standard | Roche Diagnostics GmbH | JIT | Class II | |
| K051999 | Biscover LED | Bisco Inc | EBD | Class II | |
| K051995 | Profemur Renaissance Hip Stem | Wrightmedicaltechnologyinc | JDL | Class III | |
| K051947 | Radionics Cusa Excel Ultrasonic Surgical Aspirator System with Bone | Radionics, A Division of Tyco Healthcare Group LP | LFL | Unclassified | |
| K051946 | Modus Modular Distraction Osteogenesis System | Medartis AG | MQN | Class II | |
| K051860 | Flexible Introducer Cannula, Model 135-1837 | Epimed International, Inc. | MIA | Class II | |
| K051853 | Cardiostream Sonoaim | Cardiostream, LLC | LLZ | Class II | |
| K051841 | Wh Accu Test One-Step Urine/serum Combo Pregnancy Test | W.H.P.M., Inc. | JHI | Class II | |
| K051642 | Fr.o.h. Calcaneus Repair System | I.T.S. Implantat-Technologie-Systeme GmbH | NDF | Class II | |
| K051564 | Olympus Crp Latex Reagent, Osr6199; Olympus Crp Latex Calibrator Normal Set, Odc0026; Olympus Crp Latex Calibrator High | OLYMPUS Corporation of the Americas | NQD | Class II | |
| K051445 | Milliken Silver Wound Dressings | Milliken Chemical | FRO | Unclassified | |
| K051427 | Gc Fuji Fil Lc | GC America Inc. | EMA | Class II | |
| K051236 | Resorb-X Sf | KLS-Martin L.P. | JEY | Class II | |
| K050827 | Normocard 25 (Sterile Bicarbonate Renal Dialysis Concentrate) | Dialysis Solutions, Inc. | KPO | Class II | |
| K033863 | Ox-Gen Flexible O2 Generation System, Model 6-Ox-03 | Ox-Gen, Inc. | CAW | Class II | |
| K052200 | Tem 3000 Head Coil | Mr Instruments, Inc. | MOS | Class II | |
| K052082 | Ferritin on the Access Immunoassay Systems, Model 33020 | Siemens Healthcare Diagnostics Inc. | JMG | Class II | |
| K051980 | Dvt Scanner | Dental Imaging Technologies Corporation | JAK | Class II | |
| K051960 | Cardionavigator + | GE Healthcare | DXH | Class II | |
| K051920 | Volcano S5 Imaging System, Model 804200-001 | Volcano Corporation | IYO | Class II | |
| K051863 | Amluck, Ya Horng | Ya Horng Electronic Co., Ltd. | DXN | Class II | |
| K051690 | Vygon Nutriline Catheters | Vygon Corp. | LJS | Class II | |
| K051643 | Sterrad Sterilizer Cyclesure Test Pack | Advanced Sterilization Products | FRC | Class II | |
| K051348 | Conserve Total Femoral Head | Wrightmedicaltechnologyinc | JDL | Class III | |
| K051273 | Divas Dual Pleasure Male Latex Condom | Eagle Twe, Inc. | HIS | Class II | |
| K050851 | Delta Punctum Plug | Delta Life Science, Inc. | LZU | Unclassified | |
| K052166 | Modification to: Rx Accunet Embolic Protection System | Boston Scientific Corporation | NTE | Class II | |
| K051996 | Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30 | Diomed, Inc. | GEX | Class II | |
| K051973 | Modification to: Xia Stainless Steel System | Howmedica Osteonics Corp | KWP | Class II | |
| K051824 | Invader Ugt1a1 Molecular Assay | Third Wave Technologies, Inc. | NTI | Class II | |
| K051344 | Colonic and Enema Nozzle | Ultimate Concepts, Inc. | KPL | Class II | |
| K051337 | Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859Xx; Volcano Vh-Ivus System, Model 8049Xx-001 | Volcano Corporation | OBJ | Class II | |
| K051305 | Cs Medical Td-100 Transesophageal Probe Disinfector, Model Td-100, Cs Medical Td-5 High-Level Disinfectant, Model Td-5 | CS Medical LLC | PSW | Class II | |
| K051186 | Micropulse Phacoemulsification System | Trillium Medical, Inc. | HQC | Class II | |
| K050969 | Inclose Surgical Mesh System | Anulex Technologies, Inc. | FTL | Class II | |
| K043465 | 2.5 Mm Turbo Clirpath Excimer Laser Catheter, Model 225-011 | Spectranetics Corp. | PDU | Class II | |
| K043075 | Tenacore Transducers for Fetal Ultrasonic and Tokodynamometer Monitoring | Tenacore Holdings, Inc. | HGM | Class II | |
| K052111 | Xltek Clear Signal Sub-Dermal Needle, Models 102889, 102798, 102799, 102382 | Excel Tech., Ltd. | GXZ | Class II | |
| K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | KWP | Class II |