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 |
|---|---|---|---|---|---|
| K800732 | Meniscotome | Stainless Mfg., Inc. | HXP | Class I | |
| K800731 | Meniscal Saw | Stainless Mfg., Inc. | HXP | Class I | |
| K800730 | Retrograde Knife | Stainless Mfg., Inc. | HXP | Class I | |
| K800729 | Probe | Stainless Mfg., Inc. | HXB | Class I | |
| K800703 | Modified Catheter Package | Hancock Laboratories, Inc. | DQO | Class II | |
| K800663 | Mark III | Applied Science Laboratories | DXN | Class II | |
| K800662 | Mark II | Applied Science Laboratories | DXN | Class II | |
| K800661 | Model S/d-600 Auto Inflate Control Modul | Applied Science Laboratories | DXN | Class II | |
| K800659 | Schiller Msg-1 | Renesco International, Inc. | DPS | Class II | |
| K800645 | Cyberlith Implantable Pulse Gen. #253-04 | Intermedics, Inc. | DXY | Class III | |
| K800613 | Angioplasty Injector | Medrad, Inc. | DXT | Class II | |
| K800611 | Bougie a Boule | G.D. Searle and Co. | KOE | Class II | |
| K800610 | Urethral Sound | G.D. Searle and Co. | KOE | Class II | |
| K800608 | Stone Dislodger | G.D. Searle and Co. | FFL | Class II | |
| K800607 | Suprapubic Trocar | G.D. Searle and Co. | KOB | Class II | |
| K800579 | Beta-Ase Tubes | Microchemical Specialities, Co. | JTO | Class I | |
| K800569 | Syringe Infusion Pump #2720 | Harvard Apparatus, Inc. | FRN | Class II | |
| K800566 | Cambridge Vs-550 Electrocardiograph | Cambridge Instruments, Inc. | DPS | Class II | |
| K800539 | Disp. Hydrogen & CO2 Generator Envelope | BD Becton Dickinson Vacutainer Systems Preanalytic | KZJ | Class I | |
| K800525 | Medical Components IV Catheter | Medical Components, Inc. | FOZ | Class II | |
| K800510 | Rectal & Harris Flush Tubes | Medi-Craft, Ltd. | KNT | Class II | |
| K800508 | Stomach Tubes | Medi-Craft, Ltd. | KNT | Class II | |
| K800507 | Feeding Tubes | Medi-Craft, Ltd. | KNT | Class II | |
| K800505 | Urethral Catheter | Medi-Craft, Ltd. | KOD | Class II | |
| K800500 | Pulseometer | Kirklands Sporting Goods Co. | DRT | Class II | |
| K800495 | Sur-Fit Urostomy Pouch & Urinary Bag | E. R. Squibb & Sons, Inc. | EXB | Class I | |
| K800447 | Sears All-in-the-Ear Hearing Aid #8149Hf | Int'L Hearing Aids, Inc. | ESD | Class I | |
| K800446 | Sears All-in-the-Ear Hearing Aid #8149 | Int'L Hearing Aids, Inc. | ESD | Class I | |
| K800441 | Rudd-Clinic Hemorrhoidal Forceps | J. Sklar Mfg. Co., Inc. | KOA | Class I | |
| K800425 | Gambro Ak-10-Udm-10-a Ultradiffusion | Gambro, Inc. | FKP | Class II | |
| K800330 | Model 7200 Hemodialysis Delivery System | BD Becton Dickinson Vacutainer Systems Preanalytic | FKP | Class II | |
| K800305 | Water Conductivity Monitor & Controller | Darco Water Systems, Inc. | FIP | Class II | |
| K800092 | Combison Computer | Kt Medical, Inc. | DQK | Class II | |
| K792513 | Hemodialysis Concentrate Solution | Mid Atlantic Nephrology Center | KPO | Class II | |
| K791496 | Low Plasticizer Administration Sets | Travenol Laboratories, S.A. | FPA | Class II | |
| K800594 | Ventre/sep Cortisol Ria | Ventrex Laboratories, Inc. | CGR | Class II | |
| K800590 | Bun Kit | Nobel Scientific Industries, Inc. | CDS | Class II | |
| K800589 | Glucose Oxidase Reagent | Nobel Scientific Industries, Inc. | CGA | Class II | |
| K800588 | Nsi Calibrator Set | Nobel Scientific Industries, Inc. | JIS | Class II | |
| K800586 | Nsi Carbon Dioxide Reagent Kit | Nobel Scientific Industries, Inc. | JFL | Class II | |
| K800581 | Tls Tm Surgical Drainage System | Glasrock Products, Inc. | GCY | Class I | |
| K800568 | Transphor Tm Ld Lactate Dehydrogenase | Corning Medical & Scientific | CFE | Class II | |
| K800555 | Partner Seven Disp. Bubble Oxygenator | Cardiovascular Research, Inc. | DTZ | Class II | |
| K800541 | Campylobacter Agar W/5-Antimicrobics | BD Becton Dickinson Vacutainer Systems Preanalytic | JSJ | Class I | |
| K800535 | 3M Disposable Skin Stapler | 3M Company | GDT | Class I | |
| K800533 | Add of Reticulocyte Count/capabilities | Abbott Medical | GKZ | Class II | |
| K800493 | Bactogen-H. Influenzae Type B | Armkel, LLC | GRO | Class II | |
| K800361 | Hemato-Chex | Streck Laboratories, Inc. | JPK | Class II | |
| K800335 | Krymed Liquid Nitrogen Cryojet | Cryomedics LLC | GEH | Class II | |
| K800059 | Compur M-1000 Mini-Photometer | Miles Laboratories, Inc. | KHG | Class II |