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 |
|---|---|---|---|---|---|
| K052414 | Reprocessed Electrophysiology Catheter | Alliance Medical Corp. | NLH | Class II | |
| K052405 | Sterling Interferenc Screw Ht | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | HWC | Class II | |
| K052252 | Contrast Media Transfer Sets | B.Braun Medical, Inc. | FPA | Class II | |
| K051658 | Infinity Alpha | Draeger Medical Systems, Inc. | MHX | Class II | |
| K053114 | Silverfil | Dunia Perwira Manufacturing Sdn. Bhd. | EJJ | Class II | |
| K053014 | Poly Siloxane Impression Material | Den-Mat Holdings, LLC | ELW | Class II | |
| K052861 | Modification To:sanarus Visica Treatment System , Models Vs2000 | Sanarus Medical, Inc. | GEH | Class II | |
| K052596 | Modular Thumb Implant, Models 17065,17066,17243,17067,17199,17238,17005,17239,17006,17240,17007,17241,17500,17501,17507 | Biopro, Inc. | KYI | Class II | |
| K052526 | Novus 3000 Laser System and Delivery Devices | Lumenis Ltd | GEX | Class II | |
| K051711 | Pleurx Peritoneal Catheter Kit and Pleurx Drainage Kits | Denver Biomedical, Inc. | PNG | Class II | |
| K051023 | Topez Total Ankle Replacement | Topez Orthopedics, Inc. | HSN | Class II | |
| K052876 | Telithromycin 15Ug Bbl Sensi-Disc | Becton Dickinson & Co | JTN | Class II | |
| K052852 | Superdimension/bronchus Premium | Medtronic, Inc. | JAK | Class II | |
| K051886 | Olympus Choledochoscope, Model Xchf-Bp160f | Olympus Medical Systems Corp. | FBN | Class II | |
| K051492 | Aeskulisa Asca a | Aesku, Inc. | NBT | Class II | |
| K050473 | Rbk Patella Femoral Knee | Global Orthopaedic Technology, USA, Inc. | KRR | Class II | |
| K053026 | Kowa Nonmyd 7, Kowa Nonmyd a-D | Kowa Co., Ltd. | HKI | Class II | |
| K053025 | Jostra Hlm Tubing Set | MAQUET CARDIOPULMONARY GmbH | DWE | Class II | |
| K052860 | Cg Future Annuloplasty Band | Medtronic Heart Valves | KRH | Class II | |
| K052829 | Wristox Model 3100 Pulse Oximeter | Nonin Medical, Inc | DQA | Class II | |
| K052763 | Stella Cervical Plate | Scient'X | KWQ | Class II | |
| K052703 | Alden Classic (Polymacon) Multifocal (Spherical and Toric), Alden Classic 55 (Methafilcon a) Multifocal (Spherical | Alden Optical Labs., Inc. | LPL | Class II | |
| K052636 | Teh Loong Powder Free Synthetic Vinyl Patient Examination Gloves, Yellow | Teh Loong Corp. | LYZ | Class I | |
| K052605 | External Fixation | Gexfix USA, Inc. | KTT | Class II | |
| K052474 | Nipro Hypodermic Needle | Nipro Medical Corporation | FMI | Class II | |
| K052331 | Acuson Cypress Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | |
| K052256 | Angiojet Xpeedior 120 Catheter | Possis Medical, Inc. | QEZ | Class II | |
| K052201 | Solanas Posterior Stabilization System | Alphatec Spine, Inc. | KWP | Class II | |
| K052186 | Nellcor Oximax Pulse Oximetry Sensons (Max-a, Max-Al, Max-N, Max-I, Max-P | Medtronic, Inc. | DQA | Class II | |
| K051757 | Calcium Advance Assay, Model 145-20, 145-25, 145-20-91 | Sekisui Diagnostics P.E.I. Inc. | CJY | Class II | |
| K051450 | Extended Measurements System | Inovise Medical, Inc. | DQD | Class II | |
| K040832 | C-Port Anastomosis System (Deployment System, Clip, Accessories), Model Fg-000050 | Cardica, Inc. | FZP | Class II | |
| K053040 | Paracem Universal Dc | Coltene /Whaledent AG | EMA | Class II | |
| K052978 | Ge 1.5T Signa HDE Mr System | GE Healthcare | LNH | Class II | |
| K052916 | USA Instruments 3.0T Brain/spine Array | GE Healthcare Coils | MOS | Class II | |
| K052903 | Pediatric Feeding Tube | Promedic, Inc. | KNT | Class II | |
| K052838 | Liquichek Diabetes Control, Level 1,2,3,4 | Bio-Rad | GGM | Class II | |
| K052647 | Clini-Lase System, Models Cl-Base, Cl-2000, Cl-1200, Cl-500, Cl-300, Cl-275, Cl-155, Cl-55, Clp-Base, Clp-275, Clp-55. | American Spine Center, Ltd. | ILY | Class II | |
| K052393 | B. Braun Modified Bicarbonate Dialysate | B.Braun Medical, Inc. | KPO | Class II | |
| K052314 | Dynarex Vaginal Specula 4900, Models 4911-Small, 4912-Medium, 4913-Large | Dynarex Corp. | HIB | Class II | |
| K052228 | Smit Sleeve | Nucletron BV | JAQ | Class II | |
| K052148 | Total Iron-Binding Capacity Calibrator Set. Direct Tibc Calibrator Set | Reference Diagnostics, Inc. | JIT | Class II | |
| K052075 | Procedur-10 | Avanca Medical Devices, Inc. | FMF | Class II | |
| K050609 | Aquadex System | Chf Solutions, Inc. | KDI | Class II | |
| K050550 | Gyrus General Purpose Electrosurgical Generator | Gyrus ACMI, Inc. | GEI | Class II | |
| K053046 | Iluma Orthocat/dentalcat | Imtec Corp. | JAK | Class II | |
| K053018 | Poly Siloxane Impression Material | Millennium Dental International, Inc. | ELW | Class II | |
| K052995 | Advantage Workstation 4.3. | GE Healthcare | LLZ | Class II | |
| K052987 | Breast Immobilization and Biopsy Device, Models Bi 160-O, Bi 160-Pa and Bi 160-Cc | Noras Rontgen-Und Medizintechnik GmbH | LNH | Class II | |
| K052897 | Ge Definium Amx 700, Model Amx 700 | General Electric Medical Systems | IZL | Class II |