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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K872190 | Nova 13 Sodium/potassium/chloride/lithium Analyzer | Nova Biomedical Corporation | JGS | Class II | |
| K872188 | Macconkey W/sorbitol | Remel Inc | JSI | Class I | |
| K872018 | Kotex Stick Tampons, Regular and Super | Kimberly-Clark Corporation | HEB | Class II | |
| K871998 | Groshong Cv Catheter Repair Kit | Catheter Technology Corp. | LJS | Class II | |
| K871986 | Model 5600B Programmer, Pacemaker | Telectronics, Inc. | KRG | Class III | |
| K871971 | Modified Pace*aid Model 53 | Cardiac Resucitator Corp. | DRO | Class II | |
| K871944 | Futurecare Carelynk System (Entire System) | Futurecare Systems, Inc. | DSH | Class II | |
| K871864 | Pb240 Patient Monitor/pulse Oximeter | Medtronic, Inc. | DQA | Class II | |
| K871842 | Two Fluid i.v. Sets | Panamedix, Inc. | FPA | Class II | |
| K871841 | Three Fluid i.v. Sets | Panamedix, Inc. | FPA | Class II | |
| K871775 | Stat-Vac Chest Drainage System | Gish Biomedical, Inc. | DTN | Class II | |
| K871771 | Comfortweigh | Curlington Industrial Electronics, Inc. | FRW | Class I | |
| K871718 | Modified Model Ua-711 Digital Sphygmonometer | A and D Engineering, Inc. | DSK | Class II | |
| K871682 | Wallach Convertible Colposcope | CooperSurgical, Inc. | HEX | Class II | |
| K871600 | Sysmex M-2000 18-Parameter, Fully Auto Hema Analy. | Toa Medical Electronics USA, Inc. | GKZ | Class II | |
| K871538 | Stat-Pad (Tm) | Cardiac Resucitator Corp. | DRO | Class II | |
| K871493 | Denti-Tray(tm) | Advanced Medical, Inc. | EKW | Class I | |
| K871209 | Norfolk Medical Norport | Norfolk Medical Products, Inc. | LJT | Class II | |
| K871153 | Catheter Introducer | Angeion Corp. | DYB | Class II | |
| K864592 | Judd Urethal Catheter Container | Phil Judd, Inc. | KOD | Class II | |
| K864411 | Pulse/b.p. Monitor | Pulse Time Products, Ltd. | DXN | Class II | |
| K863790 | J-Cath, Gish Model No. Jvac-Xxxx | Gish Biomedical, Inc. | DQY | Class II | |
| K863589 | Model 600 Vascular Duplex Imager | Multigon Industries, Inc. | DXK | Class II | |
| K872213 | Transtube Mw176 Ot Md176 | Medical Wire and Equipment Co. Ltd. | JSM | Class I | |
| K872209 | Arthroplasty Mallet | New England Surgical Instrument Corp. | HXL | Class I | |
| K872171 | Periotest | Siemens Medical Solutions USA, Inc. | EKX | Class I | |
| K872105 | Kodak Ektachem 700Xr Analyzer | Eastman Kodak Company | JJE | Class I | |
| K872092 | Osteotome Set, Hoke, Straight, Set of 5 | Military Engineering, Inc. | KDG | Class I | |
| K872003 | Kinderwrap | The Kinder Co. | GAX | Class I | |
| K871956 | Modular Range of Ring Pros. for Hip Replacement | Downs Surgical, Ltd. | KWA | Class III | |
| K871894 | Kck Industries' Surgical Instruments | Kck Industries | GDX | Class I | |
| K871872 | Hi Marc Interlocking Nail | Depuy, Inc. | HSB | Class II | |
| K871857 | Hps II Calcar Femoral Prosthesis | Depuy, Inc. | JDI | Class II | |
| K871160 | Truetech Medical, Inc. Denture Cups | Zenex Medical, Inc. | ELM | Class II | |
| K870983 | Nocturnal Penile Tumescence Monitor | Texas Medical Electronics Co. | LIL | Unclassified | |
| K864983 | Cusa System 200 Macro-Dissector | Cooper Lasersonics, Inc. | LFL | Unclassified | |
| K864470 | Hemorest(tm) | Health Aid Products | LRL | Unclassified | |
| K872210 | Impression Tray | Dentsply Intl. | EBH | Class I | |
| K872193 | Fletcher's Medium & Fletcher's Medium W/5-Fu | BD Becton Dickinson Vacutainer Systems Preanalytic | KZI | Class I | |
| K872061 | Lp Lateral Fluoro Positioner (B5077a) | General Electric Co. | JAA | Class II | |
| K871959 | Frantz Imaging Compact Camera | Frantz Imaging, Inc. | LMC | Class II | |
| K871958 | Spacemiser 8-17 Film Recorder | Frantz Imaging, Inc. | LMC | Class II | |
| K871957 | Spacemiser 8-10 Film Recorder | Frantz Imaging, Inc. | LMC | Class II | |
| K871743 | Video Plus Models Vp500, Vp500a and Vp1000 | Camtronics, Ltd. | JAA | Class II | |
| K871737 | Ck 7000 Series 5 in 1 Connector and Y-Connector | Currie Medical Specialties, Inc. | BZA | Class I | |
| K871624 | Thora-Drain(r) Abt System | Sherwood Medical Co. | CAC | Class II | |
| K871568 | Pleura-Gard Ats | Conmedcorp | CAC | Class II | |
| K871547 | Ultra-Violet Bun Reagent Kit (Rate) | Biochemical Trade, Inc. | CDQ | Class II | |
| K871543 | Alkaline Phosphatase (Ap) for Cont. Flow Instru. | Catachem, Inc. | CJE | Class II | |
| K871452 | Classic (Tm) 200 Oxygen Flowmeter | The Timeter Group | CAX | Class I |