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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K853156 | Echo Type 16 Cf Antigen | Hillcrest Biologicals | GNK | Class I | |
| K852244 | Hearing Aid(all in Ear) | Olympia Instruments, Inc. | ESD | Class I | |
| K854171 | I.s.m. Product Family Model P2400c,a & Abc | Intl. Solarium Manufacturer, Inc. | FTC | Class II | |
| K854034 | Snap-Lock Additive Cap #Sl 300 | Williams Medical Co. | KPE | Class II | |
| K854033 | Snap-Lock Additive Cap #Sl400 | Williams Medical Co. | KPE | Class II | |
| K854031 | Snap-Lock Additive Cap #Sl100 | Williams Medical Co. | KPE | Class II | |
| K853998 | Guiding Catheter | Target Therapeutics | DQY | Class II | |
| K853985 | Mvm 4000 Holter IV Recorder | Mountain View Medical | DSH | Class II | |
| K853830 | Sliding Reconstitution Device W/admix Vialex Plast | Travenol Laboratories, S.A. | LHI | Class II | |
| K853513 | Drake Willock 480 Uf Control Idalysate Delivery Sy | Cd Medical, Inc. | FKP | Class II | |
| K853322 | Medtronic Access Port Model 8500 | Medtronic, Inc. | LJT | Class II | |
| K853134 | National Med Care Infusion Pump Adm Set #95-0001-8 | Erika, Inc. | FRN | Class II | |
| K853124 | Novametrix Pulse Oximeter, Model 500 | Novametrix Medical Systems, Inc. | JOM | Class II | |
| K852197 | Lap-Cath | Research Medical, Inc. | DQO | Class II | |
| K854271 | Asa Blood Tubing Lines | bioMerieux, Inc. | FJK | Class II | |
| K854167 | Tdx Phencyclidine | Abbott Medical | LCM | Unclassified | |
| K854163 | Tdx Cocaine Metabolite | Abbott Medical | DIO | Class II | |
| K854161 | Sur-Fit Face Mask | Anesthesia Respiratory Technology, Inc. | BSJ | Class I | |
| K854152 | Technicon Ra Systems for Triglycerides Analysis in | Technicon Instruments Corp. | CDT | Class I | |
| K854139 | Kodak Ektachem Clinical Chemistry Slide Hb | Eastman Kodak Company | KHG | Class II | |
| K854130 | Demand Ethyl Alcohol | Cooper Biomedical, Inc. | DIC | Class II | |
| K854114 | Coulter Counter Model T-660 | Coulter Electronics, Inc. | GKL | Class II | |
| K854011 | Renalfo Hemofilter Cavhd | Renal Systems, Inc. | KDI | Class II | |
| K854000 | Infusion Catheter W/side Holes | Target Therapeutics | DQY | Class II | |
| K853999 | Guide Wire | Target Therapeutics | DQX | Class II | |
| K853997 | Infusion Catheter | Target Therapeutics | DQY | Class II | |
| K853666 | Endodynamics Siegel Theraputic Stent | E-Z-EM, Inc | FGE | Class II | |
| K853649 | Power Drive Wheelchair | Everest & Jennings, Inc. | ITI | Class II | |
| K853518 | Lifeline Endocardial Bipolar Lead 476-06 | Intermedics, Inc. | DTB | Class III | |
| K853424 | The Mover | Invacare GmbH | IOR | Class I | |
| K853384 | E-Z-Em Gastric Lavage Catheter | E-Z-EM, Inc | KNT | Class II | |
| K853328 | Koagulab 16-S Semi-Automated Coagulation Sys | Ortho Diagnostic Systems, Inc. | JPA | Class II | |
| K853297 | Multiple | Sun Air, Inc. | ISA | Class I | |
| K853253 | Corpak Farrell Valve Enteral Gastric Pressure Reli | Corpak Co. | KNT | Class II | |
| K853239 | Heptest-a Quantitative Heparin in Plasma Assay | Haemachem, Inc. | KFF | Class II | |
| K853209 | Compas 1 | Cardiac Care Units, Inc. | DSI | Class II | |
| K853163 | Setma Vht | Setma, Inc. | ILJ | Class II | |
| K853036 | Picoscale Laborscale, #Psl-1 & Analyser, #Psa-1 | Diagnostic Technology, Inc. | GKL | Class II | |
| K852969 | Rotaclone Rotavirus Diagnostic Kit | Cambridge Bioscience Corp. | LIQ | Class I | |
| K852905 | Cr 280/45, Cr281/4 Defibrillator | Cardiac Recorders, Ltd. | LDD | Class II | |
| K852812 | Comfort + Lift | Invacare GmbH | INO | Class II | |
| K852791 | 7 French Dual Lumen Com Cent Vein Cath Sys | Cardio-Vascular Innovations, Inc. | DQY | Class II | |
| K852490 | Uri-Cath System | Gesco Intl., Inc. | KNX | Class II | |
| K852152 | Flexistand Major | Zygotek Assoc. | |||
| K851153 | Coatron F(same as Coatron, but Also Does Fibrinoge | Astral Medical Systems | JPA | Class II | |
| K850812 | Emergipace - External Pacemaker | Life Science Instrumentation, Inc. | DRO | Class II | |
| K841245 | Enzygnost Antiherpes Simplex Virus | Behring Diagnostics, Inc. | GQO | Class II | |
| K854173 | Ucd Urine Specimen Collector | Baker Instructions Corp. | KNX | Class II | |
| K853680 | Endodynamic Siegel Sphincterotome | E-Z-EM, Inc | KNS | Class II | |
| K853598 | Ophthalmic Knife W/removale Depth Guide | Myocure, Inc. | HNN | Class I |