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 2026-10-08, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.

Show the numbers

510(k) clearances by decision year, the last 15 years of ingested records
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

176,299 records, page 3395 of 3526

510(k) clearances, page 3395 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K791362	Electrosurgical Cut and Coagu Accessory	Intermedics, Inc.	GEI	Class II	1979-09-04
K791360	Kodak Ortho M Film	Eastman Kodak Company	IWZ	Class I	1979-09-04
K791358	Fibro-Tec Test Kit	Calbiochem-Behring Corp.	GHH	Class II	1979-09-04
K791232	Dac-Cel T3	Burroughs Wellcome Co.	CDP	Class II	1979-09-04
K791231	Dac-Cel T4	Burroughs Wellcome Co.	CDX	Class II	1979-09-04
K791217	Tsh Ria Kit	Antibodies, Inc.	JLW	Class II	1979-09-04
K791162	Gelskin	Spenco Medical Corp.	ILO	Class II	1979-09-04
K791131	Flu Ven Tr-1	Venospital, Inc.	KSB	Class II	1979-09-04
K791130	Flu-Ven Tk-2	Venospital, Inc.	KSB	Class II	1979-09-04
K791116	Psoralite Series 30,000	Paul B. Elder Co.	KGL	Class II	1979-09-04
K791114	Bili-Dosimeter	Olympic Medical Corp.	LBI	Class II	1979-09-04
K791066	Glucose God-Pap Trinder Method Test Kit	Fermco Biochemics, Inc.	CGA	Class II	1979-09-04
K791041	Hematrak Abnormal Recognition	Geometric Data, Div. Smithkline Corp.	GKZ	Class II	1979-09-04
K791039	Fetasonde Fetal Heart Rate Variability	Roche Medical Electronics, Inc.	HGM	Class II	1979-09-04
K791038	Fetasonde Uterine Activity Monitor	Roche Medical Electronics, Inc.	HGM	Class II	1979-09-04
K791037	Fetasonde Labor Status Display	Roche Medical Electronics, Inc.	HGM	Class II	1979-09-04
K791036	Fetasonde Uterine Work Monitor	Roche Medical Electronics, Inc.	HGM	Class II	1979-09-04
K791035	Fetasonde Fetal Activity Monitor	Roche Medical Electronics, Inc.	HGM	Class II	1979-09-04
K791014	Dental Xeroradiography	Xerox Medical Systems	EAP	Class II	1979-09-04
K791000	Vitreous Suction/cutter	Concept, Inc.	HKP	Class II	1979-09-04
K790936	Model 114 Treonic H150 Haemoheater	Vickers America Medical Corp.	KZL	Class II	1979-09-04
K790895	Tongue Scraper	Peter G. Finamore, Sr.	LCN	Class I	1979-09-04
K790827	Rp-610 Parallel Plate Dialyzer	Hospal Medical Corp.	KDI	Class II	1979-09-04
K790713	Antiserum to Human Hemopexin	Kent Laboratories, Inc.	CZX	Class II	1979-09-04
K790711	Antisera to Human Fragment	Kent Laboratories, Inc.	DFK	Class I	1979-09-04
K790702	Antiserum, Human, Igg H & L Chain	Kent Laboratories, Inc.	DEW	Class II	1979-09-04
K791619	Dynamic Hip Screw	Synthes (USA) Products LLC	KTT	Class II	1979-08-28
K791565	Parapodium	Physico-Medical Systems Corp.	IQI	Class I	1979-08-28
K791500	Barrier 450 Tape Strip	Surgikos, Inc.	KKX	Class II	1979-08-28
K791499	Ray-Ban Sun Glasses	Bausch & Lomb Incorporated	HQY	Class I	1979-08-28
K791498	Adapter-Y Type/coronary Perfusion	Dlp, Inc.	DTL	Class II	1979-08-28
K791487	Model 78520A Arrhythmia Monitoring Sys	Hewlett-Packard Co.	DSI	Class II	1979-08-28
K791486	Fabric 450* Towel Drape	Surgikos, Inc.	KKX	Class II	1979-08-28
K791469	Manifold/nebulizer Breathing Products	Hospitak, Inc.	BZO	Class I	1979-08-28
K791445	Two-Piece Ippb Manifold Machines	Airlife, Inc.	CAF	Class II	1979-08-28
K791444	Universal Two-Piece Machines	Airlife, Inc.	CAF	Class II	1979-08-28
K791443	Two-Piece Ippb Manifold for Supply Line	Airlife, Inc.	CAF	Class II	1979-08-28
K791440	Barrier* X-Ray Cassette Drape	Surgikos, Inc.	KKX	Class II	1979-08-28
K791439	Barrier* Overhead Table Drape	Surgikos, Inc.	KKX	Class II	1979-08-28
K791438	Barrier* C-Arm Drape	Surgikos, Inc.	KKX	Class II	1979-08-28
K791430	Miniprime Hypothermic Heat Exchanger	Travenol Laboratories, S.A.	DTR	Class II	1979-08-28
K791426	Peritoneal Pac	Intermed, Inc.	KDJ	Class II	1979-08-28
K791424	Dcg-VII Electrocardioscanner	Del Mar Avionics	DSI	Class II	1979-08-28
K791421	Miniscope Ms-2B Electrocardioscope	Renesco International, Inc.	DPS	Class II	1979-08-28
K791420	Minigraph Mg-I Electrocardiograph	Renesco International, Inc.	DPS	Class II	1979-08-28
K791369	Airstrip Theatre Ward Dressing	Acme United Corp.	NAD	Class I	1979-08-28
K791324	Micromedic Aps2	Micromedic Systems	JQW	Class I	1979-08-28
K791237	Pyrolite Carbon Endosseous Dental Impl	Carbomedics, Inc.	DZE	Class II	1979-08-28
K791207	Apollo Heart Rate Indicator	Key Tronic Corp.	HCC	Class II	1979-08-28
K791133	Abcor Caries Detector Monitor	Abcor, Inc.	LFC	Class II	1979-08-28