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 3474 of 3526

510(k) clearances, page 3474 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K771520	Esophageal Stethoscope	Labarge, Inc.	DQD	Class II	1977-09-23
K771411	Esophageal Steth. Temp. Sensor	Labarge, Inc.	BZW	Class I	1977-09-23
K771691	Angled Forcep Applier	Edward Weck, Inc.	GEN	Class I	1977-09-22
K771656	Prolactin Ria Diag. Kit	Abbott Medical	JMF	Class II	1977-09-22
K771604	Spectrophotometeo Il Model 651	Instrumentation Laboratory Co.	JXR	Class I	1977-09-22
K771600	Ultrasound	Toshiba Medical Systems	IYO	Class II	1977-09-22
K771418	Pin Retractors	Stryker Corp.	HTY	Class II	1977-09-22
K771414	T4 by Ria Diag. Kit	Biomedical Labs., Inc.	CDX	Class II	1977-09-22
K771719	Karaya Electrodes	Lectec Corp.	GXY	Class II	1977-09-20
K771716	Cymet-Plus	J.T. Baker Chemical Co.	GKK	Class II	1977-09-20
K771706	Saif-Bow	Northwest Orthodontics, Inc.	DZB	Class II	1977-09-20
K771697	Cardio-Exercise Treadmill 550	Quinton, Inc.	IOL	Class I	1977-09-20
K771693	Clirans Blood Lines Set	Terumo America, Inc.	FJK	Class II	1977-09-20
K771683	Amplifier Model N3b-EEG	Honeywell, Inc.	GWL	Class II	1977-09-20
K771682	Min-R Cassette	Eastman Kodak Company	IXA	Class II	1977-09-20
K771676	Foot Drop Boot	Medical Restraints, Inc.	IQI	Class I	1977-09-20
K771663	Probe & Catheter	Edwards Laboratories	KRB	Class II	1977-09-20
K771652	Cath-Care Tray	Latex Ind., Inc.	FCM	Class II	1977-09-20
K771651	Akro-Sil Foley Kit 5Cc	Latex Ind., Inc.	FCM	Class II	1977-09-20
K771650	Akro-Sil Foley Kit 30Cc	Latex Ind., Inc.	FCM	Class II	1977-09-20
K771648	Computer ECG Terminal	Compumed, Inc.	DXH	Class II	1977-09-20
K771628	Nsulin Ria Kit 125I	BD Becton Dickinson Vacutainer Systems Preanalytic	CFP	Class I	1977-09-20
K771623	T3 Ria	Hoffmann-La Roche, Inc.	CDP	Class II	1977-09-20
K771601	X-Ray Remote Control Table	Toshiba Medical Systems	IZZ	Class II	1977-09-20
K771599	Gamma Cameras -Gxa-301 & Gca-402	Toshiba Medical Systems	IYX	Class I	1977-09-20
K771591	Ministat-S Chemistry Analyzer	Biokinetix Corp.	JJI	Class I	1977-09-20
K771558	Silastic Brand Obstetrical Vacuum Cup	Dow Corning Corp. Healthcare Industries Materials	HDB	Class II	1977-09-20
K771550	Mrt Dispensor	Mcgaw Respiratory Therapy	CAF	Class II	1977-09-20
K771547	Petites Between-Period Protectors	3M Company	HHL	Class II	1977-09-20
K771435	Urinary Leg Bag, Steoile	Meddev International Corp.	KNX	Class II	1977-09-20
K771430	Blood Filter, W/set	Terumo America, Inc.	FPB	Class II	1977-09-20
K771696	Emodialysis Del. Sys. Model 7110	BD Becton Dickinson Vacutainer Systems Preanalytic	FKP	Class II	1977-09-15
K771694	Clirans Th 15 Hollow Fiber Dialyzer	Terumo America, Inc.	FJI	Class II	1977-09-15
K771620	Alkaline Phosphatase Isoenzy. Sub. Set	Pfizer Inc	CIN	Class II	1977-09-15
K771608	A-Gent Triglycerides	Abbott Medical	CDT	Class I	1977-09-15
K771606	Immunospot Neonatal T4 Test	Meloy Laboratories, Inc.	CDX	Class II	1977-09-15
K771605	Creatine Kinase Isoenzyme Substrate Set	Pfizer Pharmaceuticals	JHX	Class II	1977-09-15
K771603	Immochemistry System	Beckman Instruments, Inc.	CZP	Class II	1977-09-15
K771590	Thyroid Stimulating Hormone	New England Nuclear	JLW	Class II	1977-09-15
K771586	Cholopap-Hdl	Advanced Biomedical Methods, Inc.	CHH	Class I	1977-09-15
K771573	Duo-Cath Femoral	Medical Device Laboratories	FOZ	Class II	1977-09-15
K771560	Toxha Test	Burroughs Wellcome Co.	GMM	Class II	1977-09-15
K771375	Pressure Module 5M1247	Travenol Laboratories, S.A.	FKQ	Class II	1977-09-15
K771354	Parallel Plate Dialyzers	Hospal Medical Corp.	FJG	Class II	1977-09-15
K771241	Spir-E-Vac	Breathing Services, Inc.	CAN	Class I	1977-09-15
K771147	Avl Blood Gas Instrument Model 939	Jones Medical Instrument Co.	CHL	Class II	1977-09-15
K771116	Catheter, Po2, Intravasuclar, Citadel	Sherwood Medical Industries	CCE	Class II	1977-09-15
K771079	Curity Irrigation Tray	Kendall Research Center	GBX	Class I	1977-09-15
K771689	Dial X Collimator Model A&b	Bennett X-Ray Corp.	IZX	Class II	1977-09-14
K771685	Amplifier Model N5a-His	Honeywell, Inc.	DRJ	Class I	1977-09-14