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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K803136 | Conphar Crutch Tips | Conphar, Inc. | INP | Class I | |
| K803129 | Go-Between | Agri Hort | JES | Class I | |
| K803100 | Stomahesive Paste Protective Skin Barr | E. R. Squibb & Sons, Inc. | EZR | Class I | |
| K803093 | Slit Catheter System | Howmedica Corp. | |||
| K803074 | Fernoral Hip Prosthesis | Cintor Orthopaedic Div. | JDI | Class II | |
| K802921 | Iclh Tibial Plateau | Depuy, Inc. | MBV | Class II | |
| K802757 | Buffered Charcoal Yeast Extract Agar | Remel Co. | JSJ | Class I | |
| K802690 | Ultrapak Cat. #100-0251 | Occumedics, Inc. | HYG | Class I | |
| K802674 | Reservoir for Autologous Blood Transfus. | Haemonetics Corporation | CAC | Class II | |
| K802647 | Eca Gel Prouduct Reformulation | Vanaray Laboratories, Inc. | GYB | Class II | |
| K802522 | Delta-Lite Casting Tape & Splints | Johnson & Johnson Professionals, Inc. | FYH | Class I | |
| K803062 | Cath-Secure | Melissa C. Johnson | KOD | Class II | |
| K803052 | Nuffield Anesthesia Ventilator Ser. 400 | Penlon, Ltd. | BSZ | Class II | |
| K802966 | i.v. Additive Cap | Baxa Corp., Sub. of Cook Group, Inc. | KPE | Class II | |
| K802952 | Model Hec-7 Heart Evaluation Computer | Kluwe Corp. | DPS | Class II | |
| K802809 | Electron Arc Therapy | Varian Assoc., Inc. | IYE | Class II | |
| K802808 | 6Mv Port Film Capability Option | Varian Assoc., Inc. | IYE | Class II | |
| K802759 | Siemens Pho/sonic Alpha 1000 | Siemens Gammasonics, Inc. | IYO | Class II | |
| K802755 | Arterial Blood Filter Bf-37 | Delta Medical Industries | DTM | Class II | |
| K802708 | System, Echo, Pulsed Ultrasonic Diag. | General Electric Co. | IYO | Class II | |
| K802695 | Datason Rtl II | General Electric Co. | IYO | Class II | |
| K802614 | Engstrom Emma Anesthetic Gas Monitor | Lkb Instruments, Inc. | CBS | Class II | |
| K802613 | C-Pak Model 12 Artificial Kidney | Cordis US Corp. | FJI | Class II | |
| K802312 | Cc101 ECG Monitoring System | Anthro-Metrics Corp. | DSI | Class II | |
| K802024 | Gravidaphone | Solar Electronics | KNG | Class II | |
| K801338 | Cyberlith Programmer | Intermedics, Inc. | DXY | Class III | |
| K810029 | Regulator Venoset W/0.22 Micron Ivex | Abbott Medical | |||
| K803115 | Dressing Change for G Tube | American Medical Disposable, Inc. | FRO | Unclassified | |
| K810017 | Microsurg Cautery | Medical Products Development, Inc. | HQO | Class II | |
| K803185 | Non-Conductive Anesthesia Face Mask | BD Becton Dickinson Vacutainer Systems Preanalytic | BSJ | Class I | |
| K802965 | Ampco-Dressing Change Tray-Major Dc 7418 | Associated Medical Products Co. | FSM | Class I | |
| K802964 | Ampco-Dressing Change Tray-Major Dc | Associated Medical Products Co. | FSM | Class I | |
| K802610 | Alert A,hdl-Apoliporotein a, Test Kit | Hyland Therapeutic Div., Travenol Laboratories | DER | Class II | |
| K802527 | Test Kit for Detection of Antinuclear | Bartels & Stout, Inc. | DHN | Class II | |
| K802448 | Ra 80 Eiken Kit Determ. of Rheumatic F. | Syn-Kit, Inc. | DHR | Class II | |
| K803089 | Gamma-Glutamyl Transpeptidase (Ggt) | Environmental Chemical Specialties | JPZ | Class I | |
| K803088 | Magnesium Test Kit | Mallinckrodt Critical Care | JGJ | Class I | |
| K803087 | Lancer Creatinine Microsample Stat Ana | Sherwood Medical Co. | CGX | Class II | |
| K803046 | Immu-Trace T4 Ria Procedure | American Dade | CDX | Class II | |
| K803044 | Immu-Trace T3 Uptake (T3u) Reagents | American Dade | KHQ | Class II | |
| K803043 | Riaphase (125I) Prost. Acid Phosph. Kit | Beckman Instruments, Inc. | JFH | Class II | |
| K803013 | Chloride/tco2 Analyzer Reagents | Laboratory Products, Inc. | CHJ | Class II | |
| K803001 | Leeco Testo-Quant Diagnostic Kit | Leeco Diagnostics, Inc. | CDZ | Class I | |
| K802969 | Cortisol 125-I Radioimmunoassay Kit | Ria Products, Inc. | CGR | Class II | |
| K802878 | K-Kath Urethral Catheter Introducer | B & K Medical A/S | KOD | Class II | |
| K802413 | Implant. Endocardial Dish Tip Elect. Lds | Telectronics, Inc. | DTB | Class III | |
| K801802 | Electromagnetic Blood & Arterial Gauge | Medical Testing System, Inc. | DPW | Class II | |
| K801799 | Atrial/ventricular Seqential #080-20000 | Medical Testing System, Inc. | LDF | Class II | |
| K801253 | Crest Electronic Warming Blanket | Penlon, Ltd. | DWJ | Class II | |
| K803177 | Moist Heat Pack | Duro-Med Ind., Inc. | IMA | Class I |