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 |
|---|---|---|---|---|---|
| K902107 | Wilson-Cook Syringe Holders | Wilson-Cook Medical Inc. | FGE | Class II | |
| K901987 | Olympic Bili-Lite-Pad(tm) | Olympic Medical Corp. | LBI | Class II | |
| K901937 | Codman Suction Pattie | Cerenovus, Inc. | GCX | Class II | |
| K901733 | Modified Flocath Pulmonary Artery Catheter | Cardio Metrics, Inc. | DPW | Class II | |
| K901711 | Pth-Mm II 125I Radioimmunoassay (Ria) | Incstar Corp. | CEW | Class II | |
| K901645 | Anaerobic Accu-Culshure(tm) | Medical Laboratory Automation Systems, Inc. | JTX | Class I | |
| K901630 | Chempad(tm), Electroconductive Media (882.1275) | Henley Intl. | GYB | Class II | |
| K901435 | Gastrointestinal Cytology Brush | TeleMed Systems | FDX | Class II | |
| K900918 | Gambro Lundia Ic-6H Parallel Plate Dialyzer | Gambro, Inc. | KDI | Class II | |
| K900577 | 1St Response Reusable Manual Resuscitator (Adult) | Intertech Resources, Inc. | BTM | Class II | |
| K900239 | Wilson-Cook Esophageal Motility Catheter | Wilson-Cook Medical Inc. | KLA | Class II | |
| K900106 | Closed Disconnect System | Delmed, Inc. | KDJ | Class II | |
| K895710 | Abbott Lifecare 4100 Pca Infuser | Abbott Medical | FRN | Class II | |
| K902785 | Modified Models 9500,9550,9200,8200,Heart Rate Mon | Aequitron Medical, Inc. | BZQ | Class II | |
| K902655 | Gynescope Laparoscopes | Gynescope Corp. | HET | Class II | |
| K902608 | Cardiomatic Model Msc-1001 | Medical Systems Corp. | DRT | Class II | |
| K902540 | Gsi 17 Screening Audiometer | Grason-Stadler, Inc. | EWO | Class II | |
| K902531 | Exaphase, Single Phase Impression Material | G-C Intl. Corp. | EGW | Class II | |
| K902249 | Luxalloy 50 (Powder, Tablets, Predosed Capsules) | Degussa AG | EJJ | Class II | |
| K902248 | Luxalloy Caps (Predosed Capsules) | Degussa AG | EJJ | Class II | |
| K902247 | Artalloy (Powder) | Degussa AG | EJJ | Class II | |
| K902198 | Sarns Delphin Base Adapter with Battery | 3M Company | KFM | Class II | |
| K902052 | Ahydron Dental Cleaning Agent | Ivoclar North America, Inc. | EMA | Class II | |
| K902023 | Seal Rite Procedure Kit(tm) | Pulpdent Corporation | EBC | Class II | |
| K901967 | Dendia Werk Burs and Cutting Discs | Micro-Aire Surgical Instruments, Inc. | DZP | Class I | |
| K901908 | Heliolux Visible Curing Light | Ivoclar North America, Inc. | EBZ | Class II | |
| K901723 | Mdl-2000 Lasertripter | Candela Corporation | LNK | Class II | |
| K901656 | Model 9200 Respiration/heart Rate Monitor | Aequitron Medical, Inc. | BZQ | Class II | |
| K900541 | Life-Tel Cellular Transceiver | Racom, Inc. | DXH | Class II | |
| K900389 | Temporary Crown Matrix Buttons | Advantage Dental Products, Inc. | EBG | Class II | |
| K897191 | Bsi Model Tip | Bales Scientific, Inc. | LHQ | Class I | |
| K897140 | Thin Condom Ramses & Sheik | Schmid Laboratories, Inc. | HIS | Class II | |
| K897007 | Unscented Menstrual Tampon | Personal Products Co. | HEB | Class II | |
| K896480 | Siemens Sonoline Ac | Siemens Medical Solutions USA, Inc. | IYO | Class II | |
| K902383 | Steri-Cath(tm) | Concord/Portex | BSY | Class I | |
| K902359 | Surgical Video Camera, Model 9500 | Seitz Technical Products, Inc. | FWB | Class I | |
| K902264 | True/flex Humerus, Ulna and Radius Intramedullary | Applied Osteo Systems, Inc. | HSB | Class II | |
| K902241 | Slt Contact Laser Systems (Urology) | Surgical Laser Technologies, Inc. | GEX | Class II | |
| K902031 | Customed Lap Pack IV | Customed, Inc | KKX | Class II | |
| K902030 | Customed Lap Pack III | Customed, Inc | KKX | Class II | |
| K902029 | Customed Lap Pack I | Customed, Inc | KKX | Class II | |
| K901816 | Pressure Tubing and Accessories | Arbo Medical, Inc. | CAH | Class II | |
| K901680 | Bauman Rigid Laryngoscope | Palex Intl. SA | CCW | Class I | |
| K900837 | Lpi Yag Model 1003 Surgical Laser System | Laser Photonics, Inc. | GEX | Class II | |
| K896322 | Cn Gaurd, Sterile Latex Surgical Gloves | C.N. Technocrats | FGO | Class II | |
| K895709 | Abbott Patient Controlled Analgesia (Pca) Pump | Abbott Medical | FRN | Class II | |
| K902644 | Baldur Latex Examination Gloves | Hti Trading Group | LYY | Class I | |
| K902183 | S.s.c. Medical Products Home Health Care Bed | Super Sagless Corp. | FNL | Class II | |
| K901951 | Model# Mpc | Amerisys | IZO | Class I | |
| K901906 | Wet-No-More Monitor | Travis Industries, Inc. | KPN | Class II |