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 3397 of 3526

510(k) clearances, page 3397 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K791381	Coccidiodes (Cocci)	IMMY, Inc.	GMG	Class II	1979-08-16
K791361	T3 Uptake Radioimmunoassay Kit	Technia Diagnostics, Ltd.	KHQ	Class II	1979-08-16
K791341	Human Alpha, Acid Glycoprotein	Beckman Instruments, Inc.	DEX	Class I	1979-08-16
K791340	Human Alpha2 Macroglobulin	Beckman Instruments, Inc.	DEB	Class II	1979-08-16
K791339	Human Ceruloplasmin	Beckman Instruments, Inc.	DDB	Class II	1979-08-16
K791325	Autopak 12 Digoxin Test Delivery System	Micromedic Systems	DPO	Class II	1979-08-16
K791315	Spectro-Sur Set	Helena Laboratories, Corp.	JIS	Class II	1979-08-16
K791313	Ars, Chemistry	Mid Tech, Inc.	JJY	Class I	1979-08-16
K791312	Catalog #4-2520 Chloridometer Chloride	Buchler Instruments, Inc.	JIT	Class II	1979-08-16
K791302	Manual Micro Elisa Reader #2-530	Dynatech Laboratories, Inc.	JJQ	Class I	1979-08-16
K791300	Ldh Isoenzyme Control	Electrophoresis Corp. of America	JJT	Class I	1979-08-16
K791299	Cpk Isoenzyme Control	Electrophoresis Corp. of America	JJT	Class I	1979-08-16
K791294	Spirocal	Equilibrated Bio Systems, Inc.	BXX	Class I	1979-08-16
K791287	Medicor Quality Control Buffer	Medicor USA, Ltd.	JJS	Class I	1979-08-16
K791235	Cadwell 7000 Electromyograph Machine	Cadwell Laboratories, Inc.	IKN	Class II	1979-08-16
K791230	Electrosurgical Generator (Tim)	Concept, Inc.	GEI	Class II	1979-08-16
K791053	The Denver Splint	Ronald D. Shippert, M.D.	EPP	Class I	1979-08-16
K790976	Rubazyme	Abbott Medical	GOL	Class II	1979-08-16
K790949	Galvanic Unit	Rami International Corp.	ISB	Class II	1979-08-16
K790720	Antisera to Rabbit Immunoglobulin	Kent Laboratories, Inc.	DFZ	Class II	1979-08-16
K790715	Antiserum to Human Fc	Kent Laboratories, Inc.	DAS	Class I	1979-08-16
K790714	Antiserum to Human Ceruloplasmin	Kent Laboratories, Inc.	DDB	Class II	1979-08-16
K790712	Antiserum to Human, Alpha-2-Macroglobuli	Kent Laboratories, Inc.	DDB	Class II	1979-08-16
K790709	Antiserum to Rabbit Immunoglobulin	Kent Laboratories, Inc.	DFZ	Class II	1979-08-16
K791423	Toilet Trainer for Handicapped Child	Kaye Products, Inc.	ILS	Class I	1979-08-10
K791408	Mainstream Elevating Wheel Chair	Summit Services, Inc.	ITI	Class II	1979-08-10
K791406	Cam-10 Chest Shell	Lifecare Services, Inc.	BYT	Class II	1979-08-10
K791355	Ventre/sep Digoxin Radioimmunoassay Kit	Ventrex Laboratories, Inc.	DPO	Class II	1979-08-10
K791338	Dual Head Stethoscope	Amdia Medical Products	DQD	Class II	1979-08-10
K791335	Nursescope	Amdia Medical Products	DQD	Class II	1979-08-10
K791334	Multiscope	Amdia Medical Products	DQD	Class II	1979-08-10
K791333	Bowles Stethoscope	Amdia Medical Products	DQD	Class II	1979-08-10
K791297	Prisma	Lkb Instruments, Inc.	JJE	Class I	1979-08-10
K791295	Baylor Visual Fields Programmer	Schiff Harding Waite	HPT	Class I	1979-08-10
K791225	Bjork-Shiley Aortic Graft Valve Prosth	Shiley, Inc.	DXY	Class III	1979-08-10
K791224	Malibu Labs Model 800 Finger Tip Cont	Malibu Laboratories	GEI	Class II	1979-08-10
K791213	Glucose (Gdh) Reagent	Gilford Diagnostics	LFR	Class II	1979-08-10
K791212	Vitrectomy Integrating Tray Ocutome/frag	Precision Medical Instruments, Inc.	HQE	Class II	1979-08-10
K791203	Model Se-1 Eyeglass Hearing Aid	Starkey Laboratories, Inc.	ESD	Class I	1979-08-10
K791200	Pre-Dent	Fichte, Graves, and Hunt	GIM	Class II	1979-08-10
K791180	Centrifichem System 500	Union Carbide Corp.	JJG	Class I	1979-08-10
K791177	Dispiro	Utah Medical Products, Inc	BZG	Class II	1979-08-10
K791175	Analyzer, Sodium/potassium	Nova Biomedical Corporation	CEM	Class II	1979-08-10
K791141	Bilirubin Calibrator Control	Beckman Instruments, Inc.	JJX	Class I	1979-08-10
K791132	Sci-Pharm Orthodontic Adhesive	Scientific Pharmaceuticals, Inc.	DYH	Class II	1979-08-10
K791106	Sterile, Disposable Centrifuge Bowl	Travenol Laboratories, S.A.	GKT	Class II	1979-08-10
K791095	Lithicron Model 0401, Pacemaker	Medcor, Inc.	DXY	Class III	1979-08-10
K791078	Anterior/posterior Restorative, Bond	Scientific Pharmaceuticals, Inc.	EBD	Class II	1979-08-10
K791067	Sci-Pharm Paint-on Restorative	Scientific Pharmaceuticals, Inc.	EBD	Class II	1979-08-10
K791005	Chemodent Ceramic Metal	Chemodent Dental Laboratory	EJS	Class II	1979-08-10