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 | 2,732 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K912082 | Safe II | Polystan A/S | DTZ | Class II | |
| K911388 | Cavomat | Wiest USA, Inc. | IKN | Class II | |
| K910685 | Wehrs Incus and Incus-Stapes Prostheses | Smith & Nephew Richards, Inc. | ETB | Class II | |
| K903940 | Type 9210 S/ecg | S & W Medico Teknik | DSI | Class II | |
| K913946 | Imperva Dual | Shofu Dental Corp. | KLE | Class II | |
| K913737 | Il Test(tm) Cocaine | Instrumentation Laboratory Co. | JXO | Class II | |
| K915088 | Kodak Min-R Identification Camera | Eastman Kodak Company | JAC | Class I | |
| K914944 | Bennett Overhead Tube Crane Model No. B-OTC | Bennett X-Ray Corp. | IYB | Class I | |
| K914423 | Optifiber | Minimal Invasive Therapy and Diagnostics, Inc. | GEX | Class II | |
| K914369 | Qualtex Magnetic Instrument Drape | DeRoyal Industries, Inc. | KKX | Class II | |
| K914328 | Mammomat C3 and 3 Mammographic X-Ray System | Siemens Medical Solutions USA, Inc. | IZH | Class II | |
| K914077 | Repel(tm) Lite Cut Resistant Glove Liners | Depuy-Raynham | LYU | Class I | |
| K914013 | Siemens Si-400 | Siemens Ultrasound, Inc. | IYO | Class II | |
| K913671 | Human Igd Immunological Nl Test Kit | The Binding Site | CZJ | Class II | |
| K913614 | Fructosamine Abg21 Test System | Boehringer Mannheim Corp. | LCP | Class II | |
| K913355 | Luhr Pan Fixation System | Howmedica Corp. | HRS | Class II | |
| K912451 | Urodynamic Rectal Balloon | Cook Incorporated | FAP | Class II | |
| K912361 | Si-450/Ilus (Intraluminal Ultrasound) | Siemens Ultrasound, Inc. | ITX | Class II | |
| K915003 | Emit Calibrator Level 1(Cutoff)/level 2(High) | Syva Co. | DKB | Class II | |
| K914973 | Syva Emit D.a.u. Cocaine Metabolite | Syva Co. | DIO | Class II | |
| K914610 | Swede Cross Manual Wheelchair | Etac Us, Inc. | IOR | Class I | |
| K914560 | Stat Pal Sensyr Syringe Assembly for Use W/statpal | Ppg Industries, Inc. | CHL | Class II | |
| K914546 | Angled Blade Plate | Synthes (USA) Products LLC | KTW | Class II | |
| K914490 | Micro Eia for Marijuana Metabolites | Microdiagnostics, Inc. | LDJ | Class II | |
| K914470 | Pneumo-Seal(tm) | Edward Weck, Inc. | GCJ | Class II | |
| K914277 | Wallstent(r) Trans Biliary Endo W/unistep Deliv Sy | Schneider U.S. Stent Div. | FGE | Class II | |
| K914177 | Hydrodisector | Spiess Design, Inc. | JCX | Class II | |
| K914151 | Il Test(tm Digoxin | Instrumentation Laboratory Co. | KXT | Class II | |
| K913973 | Infrared Heat Lamps & Massager Model Nh-213 | National Health-Care Equipment, Inc. | ILY | Class II | |
| K913955 | 1.9 French Lithotripter Electrode, Modification | Northgate Technologies Inc. | FFK | Class II | |
| K913880 | Infrared Heat Lamp Model Nh-202 | National Health-Care Equipment, Inc. | ILY | Class II | |
| K913856 | Infrared Heat Lamp Model Nh-201 | National Health-Care Equipment, Inc. | ILY | Class II | |
| K913608 | Snapper | Healthtek, Inc. | KPE | Class II | |
| K913463 | Mag Res Imag Syst/bruker Model R28 Whole Body Scan | Bruker Medical Imaging, Inc. | LNH | Class II | |
| K913413 | Kangaroo(r) Pet(tm) Enteral Feed Pump/charger Base | Sherwood Medical Co. | LZH | Class II | |
| K913352 | C-150 Ultrafast CT Scanner | Imatron, Inc. | JAK | Class II | |
| K913150 | Abbott Matrix Aero Plus System | Abbott Medical | DHB | Class II | |
| K913106 | Abbott Imx Toxo Igm Positive Control | Abbott Medical | LGD | Class II | |
| K912956 | Atrium Dual Ats Water Seal Chest Drain Unit | Atrium Medical Corporation | CAC | Class II | |
| K912848 | i.v. Filter Extension Set | Filtertek, Inc. | FPB | Class II | |
| K912610 | Mini-Op Ats Blood Recovery Bag, Model 2955 | Atrium Medical Corporation | CAC | Class II | |
| K912609 | Mini-Op Ats Blood Recovery Bag, Moel 2950 | Atrium Medical Corporation | CAC | Class II | |
| K911883 | Daig Fast Cath(tm) Transseptal Sheath Introducer | Diag Corp. | DYB | Class II | |
| K911336 | Bird Nebulization Synchronizer | Bird Products Corp. | CBK | Class II | |
| K911206 | Maxima-10 | Stirn Industries | FLE | Class II | |
| K911143 | Pb100 Diagnostic Spirometer | Medtronic, Inc. | BZM | Class II | |
| K910481 | Epo-Ria | Ramco Laboratories, Inc. | GGT | Class II | |
| K914982 | Beltone Profile in-the-Ear Hearing Aid | Beltone Electronics Corp. | ESD | Class I | |
| K914981 | Otosonic (Osi) Lps in-the-Ear Hearing Aid | Beltone Electronics Corp. | ESD | Class I | |
| K914906 | Auto Eia Microplate Read Model Ceres 900 W/var Opt | Bio-Tek Instruments, Inc. | JJQ | Class I |