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 2026-10-05, 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 3524 of 3526

510(k) clearances, page 3524 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K760218	Cannulae, Plastic Disposable Nasal	Manner Medical Products	CAT	Class I	1976-08-03
K760206	Test, Detection, Antinuclear Antibodies	Intl. Diagnostic Technology	DHN	Class II	1976-08-03
K760196	Assay, Amphet. Ndc#11711-0127-1 Coulter	Coulter Electronics, Inc.	DKZ	Class II	1976-08-03
K760195	Reagent, Trigly. C-Zyme Ndc#12739-0017-1	Coulter Electronics, Inc.	CDT	Class I	1976-08-03
K760194	Ndc#12739-0010-1 C-Zyme Gpt	Coulter Electronics, Inc.	CKA	Class I	1976-08-03
K760193	Ndc#12739-0011-1 C-Zyme Got	Coulter Electronics, Inc.	CIT	Class II	1976-08-03
K760098	Reagent, Vdrl	Gamma Biologicals, Inc.	GMT	Class II	1976-08-03
K760097	Febrile Antigens & Control Serums	Gamma Biologicals, Inc.	GSZ	Class I	1976-08-03
K760096	Reagent, Lyophilized Anti-Streptolysin O	Gamma Biologicals, Inc.	GTQ	Class I	1976-08-03
K760063	Specimen Collector, Anaerobic	BD Becton Dickinson Vacutainer Systems Preanalytic	JTX	Class I	1976-08-03
K760054	Culture Tube, (Vacutainer)	BD Becton Dickinson Vacutainer Systems Preanalytic	JTW	Class I	1976-08-03
K760043	Test, Rheum. Arth., Card (Macro-Vue)	BD Becton Dickinson Vacutainer Systems Preanalytic	DHR	Class II	1976-08-03
K760040	Test, Mono., Card (Macro-Vue)	BD Becton Dickinson Vacutainer Systems Preanalytic	KTN	Class II	1976-08-03
K760036	Test, Latex Slide, Rheumatoid Factor	Gamma Biologicals, Inc.	DHR	Class II	1976-08-03
K760035	Test, C-Reative Protein, Latex Slide	Gamma Biologicals, Inc.	DCK	Class II	1976-08-03
K760033	Test, Antibodies for Grp a, Latex Slide	Gamma Biologicals, Inc.	GTZ	Class I	1976-08-03
K760032	Test, Mono., Differential Slide	Gamma Biologicals, Inc.	KIN	Class I	1976-08-03
K760258	Bite Stick, Dyna	Dyna-Med	JXL	Class II	1976-07-26
K760250	Bandage, Triangular No. 8068	Johnson & Johnson Professionals, Inc.	ILI	Class I	1976-07-26
K760245	Prosthesis, Richards Mod II Knee	Richard'S Medical Equip., Inc.	HRY	Class II	1976-07-26
K760240	Impression Material, Triflex Silicone	Oratec Dental Products	ELW	Class II	1976-07-26
K760239	Cement, Ultra-Bond	Oratec Dental Products	EMA	Class II	1976-07-26
K760238	Impression Material, Triflex Silicone	Oratec Dental Products	ELW	Class II	1976-07-26
K760236	Bur, Surgical Carbide	Cutter Laboratories, Inc.	HTT	Class I	1976-07-26
K760235	Suture Guide	Cutter Laboratories, Inc.			1976-07-26
K760227	Radioimmunoassay	Kallestad Laboratories, Inc.	CDX	Class II	1976-07-26
K760209	Acid, Native-Deoxyribonucleic, Ivdp	Zeus Scientific LLC	DHN	Class II	1976-07-26
K760208	Oximeter, Co-, Il Model 282	Instrumentation Laboratory Co.	KHG	Class II	1976-07-26
K760207	Kit, Folate Radioassay Sc.7	Amersham Corp.	CGN	Class II	1976-07-26
K760205	Radiographic Unit, Xrc-1	Xrc, Inc.	KPR	Class II	1976-07-26
K760084	Monitor, Gsr (Nb-401)	Narco Bio-Systems	HCC	Class II	1976-07-26
K760044	Kit, Ria, Human Thyroid Hormone	BD Becton Dickinson Vacutainer Systems Preanalytic	JLW	Class II	1976-07-26
K760011	Reagent, Triglycerides	The Dow Chemical Co.	CDT	Class I	1976-07-26
K760010	Colorimetric Determination (Sgot/sgpt)	The Dow Chemical Co.	CIT	Class II	1976-07-26
K760003	Cast Material (Wicket Stockinette)	Zimmer GmbH	ITG	Class I	1976-07-26
K760002	Knee Aid	Zimmer GmbH	IQI	Class I	1976-07-26
K760001	Arch Support (Arch Aid)	Zimmer GmbH			1976-07-26
K760231	Impression Material, Dental Silicon Rtv	Crown Delta Corp.	ELW	Class II	1976-07-21
K760226	Paste, Accoe Impression	Coe Laboratories, Inc.	ELW	Class II	1976-07-21
K760225	Putty, Accoe	Coe Laboratories, Inc.	ELW	Class II	1976-07-21
K760215	Hearing Aid, S-522 Fm	Vicon Instrument Co.	ESD	Class I	1976-07-21
K760067	Catheter, Thermal Dilution, Open Chest	Instrumentation Laboratory Co.	KRB	Class II	1976-07-21
K760066	Tray, Iced Injectable (26420)	Instrumentation Laboratory Co.	DXL	Class II	1976-07-21
K760065	Catheter, Thermal Dilution, Pediatric	Instrumentation Laboratory Co.	KRB	Class II	1976-07-21
K760064	Catheter, Thermal Dilution, Animal & Ped	Instrumentation Laboratory Co.	KRB	Class II	1976-07-21
K760200	Prosthesis, Patellar Articular Surface	Depuy, Inc.	JWH	Class II	1976-07-20
K760169	Diffusion System, Single-Breath (47404A)	Hewlett-Packard Co.	CCJ	Class II	1976-07-20
K760166	Stimulator, Sonic Control (as-1)	Farrall Instruments, Inc.	HCB	Class II	1976-07-20
K760164	Underpad, Disposable Polypropy. (Unilux)	Parke-Davis Co.	EYQ	Class I	1976-07-20
K760163	Catheter, Intravascular (Medicut T)	Sherwood Medical Industries	FOZ	Class II	1976-07-20