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 |
|---|---|---|---|---|---|
| K062290 | Microscan Microstrep Plus Panel Vancomycin (0.06 - 8 Mcg/ml) | Siemens Healthcare Diagnostics Inc. | LRG | Class II | |
| K062223 | Agfa Model Cr30-X | Agfa Corp. | MQB | Class II | |
| K061797 | Sm Implant Systems | Dio Department Dsi, Inc. | DZE | Class II | |
| K061649 | Power Circular Stapler Digital Loading Unit with and without Sheath | Power Medical Interventions, Inc. | GDW | Class II | |
| K061564 | Portland Ceramic (Biolox-Forte) Femoral Head | Portland Orthopaedics Pty., Ltd. | LZO | Class II | |
| K061231 | Wellflex Biliary Rx Stent System | Boston Scientific Corporation | FGE | Class II | |
| K061134 | Eberle Shaver System C2 and Shaver Blades | Efs Eberle Feinwerktechnische Systeme | HRX | Class II | |
| K061075 | Boomerang Wire | Cardiva Medical, Inc. | DXC | Class II | |
| K060882 | Excel Bond Dc, Model 28-200100 | J. Morita USA, Inc. | KLE | Class II | |
| K060288 | Retro Silver and Xpresso Silver Chronic Hemodialysis Catheters | Spire Biomedical, Inc. | MSD | Class II | |
| K060165 | Axyaflex Polyester Suture | TORNIER Inc. | GAT | Class II | |
| K062299 | Synthes Sterile Mandible External Fixation Kit | Synthes (USA) Products LLC | MQN | Class II | |
| K062231 | Mr Fiber Optic Intubating Laryngoscope Handle, Standard, Model 310001 | Minrad, Inc. | CCW | Class I | |
| K062230 | Mr Fiber Optic Intubating Laryngoscope Handle, Short, Model 310002 | Minrad, Inc. | CCW | Class I | |
| K062190 | Sensititre Haemophilus / Streptococcus Pneumoniae (Hp) Mic Plates | Trek Diagnostic Systems, Ltd. | JWY | Class II | |
| K061970 | Elecsys Ige II Immunoassay | Roche Diagnostics GmbH | JHR | Class II | |
| K061870 | Vitalsense Xhr | Respironics, Inc. | GWK | Class II | |
| K061566 | Primus Gps Biliary Stent System | Medtronic, Inc. | FGE | Class II | |
| K061555 | Anchor Laparscopic Tissue Retieval System | Anchor Products Co. | GCJ | Class II | |
| K061313 | Evis Exera 180 System | Olympus Medical Systems Corp. | EOQ | Class II | |
| K061248 | Axiem Imageless Hip Module for the Stealthstation System | Medtronic Navigation, Inc | HAW | Class II | |
| K061045 | Reprocessed Electrophysiology Catheters | Alliance Medical Corp. | NLH | Class II | |
| K060397 | RF Lesion Cannula, RF Thermolesion Cannula, Thermolesion Cannula, X-Ray Contrast Cannula, Cannula, Facet Deneration Need | Pajunk GmbH Medizintechnologie | GXI | Class II | |
| K053556 | Body Composition Analyzer, Models Zeus 9.9 and Venus 5.5 | Jawon Medical Co., Ltd. | MNW | Class II | |
| K052687 | Conformis, Inc. Total Knee Repair System | ConforMIS, Inc. | JWH | Class II | |
| K061686 | Idi-Vanr Assay | Geneohm Sciences Canada, Inc. | NIJ | Class II | |
| K061531 | Space Cpsxl Bone Cement | Dfine, Inc. | NDN | Class II | |
| K061353 | Trinica Anterior Lumbar Plate System | Zimmer Spine, Inc. | KWQ | Class II | |
| K060578 | Calcitonin Immunoradiometric Assay (Irma) (Coated Tube Version) | Scantibodies Laboratory Inc. | JKR | Class II | |
| K061839 | Dimension Vista Dbil Flex Reagent Cartridge, Model K2125 | Siemens Healthcare Diagnostics Inc. | CIG | Class II | |
| K061236 | Flexifit Hc432 Full Face Mask | Fisher & Paykel Healthcare, Inc. | BZD | Class II | |
| K061071 | V-808 Atom Transcapsule | Atom Medical Corporation | FPL | Class II | |
| K062225 | Halo Coagulation Catheter | Barrx Medical, Incorporated | GEI | Class II | |
| K062175 | Cryocare Cn2 System | Varian Medical Systems, Inc. | GEH | Class II | |
| K062158 | Lc Sprint Star | Pari Innovative Manufacturers, Inc. | CAF | Class II | |
| K061917 | Distal Radius Locking Plating System | Newclip Technics | HRS | Class II | |
| K061862 | Axiom Orthopaedics Shoulder Resurfacing System | Axiom Orthopaedics, Inc. | HSD | Class II | |
| K061799 | Quadratens, Model Qt-42 | Bio-Research Associates, Inc. | GZJ | Class II | |
| K061221 | Dupuy S-Rom Std Hip Stem Prosthesis | Depuy Orthopaedics Inc. | KWA | Class III | |
| K062122 | Dimension Vista System Chemistry 3 Calibrator (Chem 3 Cal - Kc130) | Siemens Healthcare Diagnostics Inc. | JIX | Class II | |
| K062121 | Dimension Vista System Drug 2 Calibrator (Drug 2 Cal - Kc420) | Siemens Healthcare Diagnostics Inc. | DKB | Class II | |
| K062088 | Premier 11 Holter | Diagnostic Monitoring Software | MLO | Class II | |
| K062036 | Micrus Microcoil System Presidio-18, Model Pc4 | Micrus Endovascular Corporation | HCG | Class II | |
| K061923 | Dimension Vista Enzyme 1 Calibrator (Enz 1 Cal - Kc310) | Siemens Healthcare Diagnostics Inc. | JIX | Class II | |
| K061738 | Albert Browne Ltd. Verify Steam and Eo Load Record Card | Sybron Dental Specialties, Inc. | JOJ | Class II | |
| K061719 | Dimension Vista Tbil Flex Reagent Cartridge, and Dimension Vista Tbil/dbil Calibrator; Models K1167, Kc212 | Siemens Healthcare Diagnostics Inc. | CIG | Class II | |
| K061701 | High Speed Air Turbine Handpieces, Par-4Hex/4hx Series (Twin Power Turbine 4H) | J. Morita USA, Inc. | EFA | Class I | |
| K061293 | Telaheart Digital Recorder | North East Monitoring, Inc. | MWJ | Class II | |
| K060720 | Curative Dental Acrylic Teeth | Curative, LLC | ELM | Class II | |
| K060677 | N Latex Cdt | Siemens Healthcare Diagnostics Inc. | NAO | Class I |