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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3133 of 3528

510(k) clearances, page 3133 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K832834	Concise 2 Small Particle Light Curved	3M Company	EBD	Class II	1983-09-29
K832810	Hard Contact Lens Cleaner	Blairex Laboratories, Inc.	HPX	Unclassified	1983-09-29
K832806	Coronary Anastomosis Marking System	Biotrac Laboratories	DSY	Class II	1983-09-29
K832800	Automatic Tangent Screen 50	CooperVision, Inc.	HOO	Class I	1983-09-29
K832797	Modifica- of Emit AED Ethosuximide Assay	Syva Co.	DLF	Class II	1983-09-29
K832792	Ames Tda Sisomicin Test-Control Serum	Miles Laboratories, Inc.	DJB	Class II	1983-09-29
K832789	After Loading Buchler	Ellis Pharmaceutical Consulting, Inc.	JAQ	Class II	1983-09-29
K832775	A-Gent Glycosylated Hemoglobin	Abbott Medical	LCP	Class II	1983-09-29
K832769	Ames Tda Kanamycin Test-Control Serum	Miles Laboratories, Inc.	KJI	Class II	1983-09-29
K832766	Ames Tda Disopyramide Test	Miles Laboratories, Inc.	KLT	Class II	1983-09-29
K832762	Miller/nadler Glare Tester	Titmus Optical, Inc.	HLX	Class II	1983-09-29
K832751	Behind-the-Ear Series 125	Danavox, Inc.	ESD	Class I	1983-09-29
K832738	Heyer-Schulte Afterloading Catheter	American Heyer Schulte	IWJ	Class I	1983-09-29
K832737	Ect Processor	Siemens Gammasonics, Inc.	JWM	Class II	1983-09-29
K832736	Kemtek 104 Ria Gamma Counter	Kemble Instruments, Inc.	JJJ	Class I	1983-09-29
K832735	Kemtek 103 Ria Gamma Counter	Kemble Instruments, Inc.	JJJ	Class I	1983-09-29
K832733	Xerox 120 Sys Mammographic X-Ray	Xerox Medical Systems	IZH	Class II	1983-09-29
K832732	Radiotherapy Mgmt. System Rms-1000	Varian Assoc., Inc.	IYE	Class II	1983-09-29
K832726	Intrinsic Factor Blocking Antibody Kit	Siemens Healthcare Diagnostics Inc.	CDD	Class II	1983-09-29
K832704	Shiley Gas Filter	Shiley, Inc.	KRI	Class I	1983-09-29
K832701	Hsi Elite #Ec Custom Canal Hear-Aid	Hearing Services, Inc.	ESD	Class I	1983-09-29
K832667	Lucae's Ear & Nasal Applicators	Kells Medical, Inc.	KCJ	Class I	1983-09-29
K832603	Curix Capacity Film Center	AGFA Healthcare Corp.	IXW	Class II	1983-09-29
K832602	Thyroid Protective Collar	E.M. Adams Co., Inc.	EAJ	Class I	1983-09-29
K832601	Leaded X-Ray Apron	E.M. Adams Co., Inc.	EAJ	Class I	1983-09-29
K832592	Diacrom * Atiii	Wellcome Diagnostics	JBQ	Class II	1983-09-29
K832559	Ocucare Freedom Pack	Ocular Innovations, Inc.	HQC	Class II	1983-09-29
K832554	Fogarty 6Mm Softjaw Clip	American Edwards Laboratories	DXC	Class II	1983-09-29
K832532	Agar Plate Xld	Otisville Biotech, Inc.	JSH	Class I	1983-09-29
K832530	Deva 4	Degussa Dental, Inc.	EJS	Class II	1983-09-29
K832495	Flynn Series III Bag/mask Unit-	O-Two Systems Intl., Inc.	BTM	Class II	1983-09-29
K832474	Fogarty-Chin Peripheral Dilation Cath	American Edwards Laboratories	LIT	Class II	1983-09-29
K832433	Automatic Spirometer St-200	Future Impex Corp.	BZG	Class II	1983-09-29
K832432	Spiro Analyzer St-100 Automatic Spiro	Future Impex Corp.	BZG	Class II	1983-09-29
K832431	Fukunda Sangya Units Pulmotester Pm60	Future Impex Corp.	BZG	Class II	1983-09-29
K832430	Fukunda Sangyo Units Electronic Spiro	Future Impex Corp.	BZG	Class II	1983-09-29
K832376	Widex Hearing Aid Model L1	Widex Hearing Aid Co., Inc.	ESD	Class I	1983-09-29
K832373	Diacrom * Heparin	Wellcome Diagnostics	KFF	Class II	1983-09-29
K832372	Diacrom * Factor X Kit Ha31	Wellcome Diagnostics	GGP	Class II	1983-09-29
K832326	Behind-the-Ear #123 Agci	Danavox, Inc.	ESD	Class I	1983-09-29
K832278	Light Handle Cover	Concept, Inc.	KKX	Class II	1983-09-29
K832243	Culture Medium for Antimicrobial Sus	Carroll Biological Corp.	JTZ	Class II	1983-09-29
K832235	Disposable Vitrectomy Handpiece	Innovative Surgical Products, Inc.	HQE	Class II	1983-09-29
K832228	Rubascan Latex Card Test	BD Becton Dickinson Vacutainer Systems Preanalytic	GOK	Class II	1983-09-29
K832211	Dosimetric Release of Gamma Radiation	Kirschner Medical Corp.	JDI	Class II	1983-09-29
K832180	Rexton Rx10, Rx20-30 & 40	Rexton, Inc.	ESD	Class I	1983-09-29
K832079	Collection Kit Chlamydia Trachomatis	Syva Co.	LIO	Class I	1983-09-29
K832078	Micro Trak Chlamydia Trac Control Slid	Syva Co.	LJP	Class I	1983-09-29
K832077	Micro Trak Chlamydia Trachomatis Direct	Syva Co.	LJP	Class I	1983-09-29
K832066	Control 282	Bio-Nustics, Inc.	JKS	Class I	1983-09-29