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 | 2,502 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K792083 | Haag-Streit Slit Lamp 900 | Lumenis Ltd | HRM | Class I | |
| K792068 | Memco 300 Film Changer | Memco, Inc. | KPX | Class II | |
| K792056 | Fisher Diagnostics Anaerobic Blood Cult | Fisher Scientific Company L.L.C. | JSC | Class I | |
| K792044 | Safe Return Cot. #9675 & Connector Adapt | Concept, Inc. | GEI | Class II | |
| K792033 | Dynacor Sterile Blood Gas Specimen Tray | MEDLINE INDUSTRIES, LP - Northfield | FMF | Class II | |
| K792011 | Tc02m Precision Gas Calibrator | Novametrix Medical Systems, Inc. | KLK | Class II | |
| K791970 | Hygenic Rubber Dam Lubricant | The Hygenic Company, LLC | KMJ | Class I | |
| K791967 | Mevatron 74X Medical Linear Accelerator | Siemens Medical Laboratories, Inc. | IYE | Class II | |
| K791948 | Fiax Test Kit for Anti-Cytomegalorirus | Intl. Diagnostic Technology | GQH | Class II | |
| K791901 | Barnes-Hind Wetting & Soaking Solution | Barnes-Hind, Inc. | HQG | Class I | |
| K791894 | 3M Brand Total Leg Compression Tlc Sys. | 3M Company | JOW | Class II | |
| K791865 | Hydron Burn Dressing Field Kit | National Patent Development Corp. | KMF | Class I | |
| K791789 | 3M Microbial Profile System Gram | 3M Company | JSS | Class I | |
| K791746 | Rotazyme | Abbott Medical | LFX | Class II | |
| K791730 | Ring-Orifice, Turbulent Flow Pneumot | Research Development Corp. | JAX | Class II | |
| K791722 | Disposable Peritoneal Dialysis Extension | American Medical Products LLC | KDJ | Class II | |
| K791598 | Closed System Foley Catherization Proced | Walpak Co. | KOD | Class II | |
| K791584 | Cyler/heater for Peritoneal Dialysis | American Medical Products LLC | KPF | Class II | |
| K791342 | Adr-10600(Adr 400),10601 (Adr 300) | Physio Control, Inc. | FKX | Class II | |
| K790526 | Lio-714 Opacitymeter | Laser Industries, Ltd. | HJL | Class I | |
| K792182 | Ice Container I.c.e. | Delta Medical Industries | IME | Class I | |
| K792181 | 3M Hs 22 Femoral Component | 3M Company | KWL | Class II | |
| K792177 | Millar Mikro-Tip Catheter Transducer | Millar LLC. | DXO | Class II | |
| K792148 | Adjustable Tube Tree for Anesth. Hoses | Medical Innovations, Inc. | JAY | Class I | |
| K792121 | Aerobitron III | Stanford Scientific, Inc. | ISD | Class II | |
| K792120 | Aerobitron II | Stanford Scientific, Inc. | ISD | Class II | |
| K791735 | Pap Ria Kit | Nuclear Medical Systems, Inc. | JFH | Class II | |
| K791582 | Cardio Ck-B Ria Kit | Nuclear Medical Systems, Inc. | JHX | Class II | |
| K791316 | Medtronic Models 5984/5985 | Medtronic, Inc. | DXY | Class III | |
| K791184 | Biobrane Brand Temporary Wound Dressing | Hall-Woodroof, Inc. | |||
| K792196 | 8 Subject Photovolt Electrolyte Serum Co | Photovolt Corp. | JJR | Class I | |
| K792192 | Vita-Stat Model 900A | Vita-Stat Medical Services, Inc. | DXN | Class II | |
| K792189 | Nordiclab Total Estriol Ria Test | Nordiclab Intl. | CGI | Class I | |
| K792183 | Dade High Density Lipoprotein Cholestero | Dade, Baxter Travenol Diagnostics, Inc. | LBS | Class I | |
| K792180 | Corning Confirm Blood Gas Quality Contro | Corning Medical & Scientific | JJS | Class I | |
| K792175 | Rianen, Vitamin B12 Assay System | New England Nuclear | CDD | Class II | |
| K792172 | Percutaneous Sheath Intro. Kit or Tray | Stanco Medical, Inc. | DYB | Class II | |
| K792171 | Complete Tray Central Venous Pressure | Stanco Medical, Inc. | DYB | Class II | |
| K792170 | Percutaneous Sheath (Multi-Cath)side | Stanco Medical, Inc. | DYB | Class II | |
| K792168 | Lifeline - Endocardial Pacing Lead | Intermedics, Inc. | DTB | Class III | |
| K792167 | 125 I Folate Solid Phase Radioassay | Abbott Medical | CGN | Class II | |
| K792166 | 125 I Prolactin Hormone Ria Kit | Siemens Healthcare Diagnostics Inc. | CFT | Class I | |
| K792157 | Dental Mouthprop (Bite Block) | Mission Dental, Inc. | JXL | Class II | |
| K792154 | Thyroid Stimulating Hormone | Radioimmunoassay, Inc. | JLW | Class II | |
| K792153 | Digoxin Radioimmunoassay System | Radioimmunoassay, Inc. | DPB | Class II | |
| K792152 | Cardioplegia Solution Admin. Set | Cardio Systems, Inc. | DWF | Class II | |
| K792151 | Oxygenator Gas Line Filter | Cardio Systems, Inc. | KRI | Class I | |
| K792149 | Mtc Oxygen Concentrator, or Prime-Aire | Molecular Technologies Corp. | CAW | Class II | |
| K792143 | Fisher Diag. Prime Blood Gas Controls | Fisher Scientific Company L.L.C. | JJS | Class I | |
| K792139 | Feather-Lite Urinary Div. Pouch | Howmedica Corp. | EXB | Class I |