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 3504 of 3526

510(k) clearances, page 3504 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K760973	Hemodialysis Cannula & Femoral Clamp	Rodell Medical, Inc.	FIQ	Class II	1977-01-12
K760969	Ph/blood Gas System	Instrumentation Laboratory Co.	CHL	Class II	1977-01-12
K760941	Mask Artificial Respiration	Gene R. Baldwin	BYG	Class I	1977-01-12
K760893	Aggrecetin	Bio/Data Corp.	JOZ	Class II	1977-01-12
K770009	Biobond C&b Post Solder	Dentsply Intl.	EJT	Class II	1977-01-10
K761360	8 Latex Extension Tube with Connector	Intermed, Inc.	KNX	Class II	1977-01-10
K761358	Coil Dialyzer Model Alt 140	Bentley Laboratories, Inc.	FHS	Class II	1977-01-10
K761337	Aquamatic K-Module Model K-10	Gorman Rupp Industries	JRR	Class I	1977-01-10
K761326	Arteriovenous Blood Tubing Sets	Extracorporeal Medical Specialities, Inc.	FJK	Class II	1977-01-10
K761314	Flexion-Braking Knee-Shin Assembly	Hosmer Dorrance Corp.	ION	Class I	1977-01-10
K761313	4-Bar Knee-Shin Set-Up	Hosmer Dorrance Corp.	ION	Class I	1977-01-10
K761312	Orthotic Bracing	Hosmer Dorrance Corp.	IQI	Class I	1977-01-10
K761177	Sodium Citrate	Bio/Data Corp.	GJE	Class II	1977-01-10
K761176	Calcium Chloride (0.025M)	Bio/Data Corp.	JPA	Class II	1977-01-10
K761175	Imidazole Buffer (0.05M)	Bio/Data Corp.	JPA	Class II	1977-01-10
K761174	Physiologic Saline (0.85%)	Bio/Data Corp.	JCE	Class I	1977-01-10
K761173	Tris Buffered	Bio/Data Corp.	JPA	Class II	1977-01-10
K761172	Tris Buffered Saline	Bio/Data Corp.	JPA	Class II	1977-01-10
K761171	Veronal Buffer	Bio/Data Corp.	JPA	Class II	1977-01-10
K761170	Barbital Saline Buffer	Bio/Data Corp.	JCE	Class I	1977-01-10
K760928	Blood Bank Dri-Bath	Thermolyne Corp.	JTQ	Class I	1977-01-10
K760918	Heparin Control Plasma	Hyland Therapeutic Div., Travenol Laboratories	GFO	Class II	1977-01-10
K760856	Blood Cell Processor Model 2 Ibm 2991	Intl. Business Machines	GKT	Class II	1977-01-10
K761346	Radioimmunoassay Kit(cortisol in Plasma)	New England Nuclear	CGR	Class II	1977-01-07
K760846	Pakostat II	Pako Corp.	EGW	Class II	1977-01-07
K761325	Model Da-53 Pressure Guage Isolator	Extracorporeal Medical Specialities, Inc.	DRS	Class II	1977-01-06
K761322	Surgical Blades	Richard-Allan Medical Ind., Inc.	GES	Class I	1977-01-06
K761318	3038 Option B-Comput. Trans. Terminal	Cambridge Instruments, Inc.	DXH	Class II	1977-01-06
K761308	Electronic Stethoscope	MEDLINE INDUSTRIES, LP - Northfield	DPD	Class II	1977-01-06
K761307	Auto Syringe Model as-3A	Baxter Healthcare Corporation	FRN	Class II	1977-01-06
K761141	Arterial Graft Sizers	Pilling Co.			1977-01-06
K761093	Bandage	Paco Pharmaceutical Services, Inc.	NAD	Class I	1977-01-06
K760995	Decollating Tray	Dravon Medical, Inc.	FJZ	Class II	1977-01-06
K760994	Monitor Line W/filter & Needle	Dravon Medical, Inc.	KOC	Class II	1977-01-06
K760786	Enzymatic Lipase Max-Pack Reagent	Calbiochem	CHI	Class I	1977-01-06
K761353	Viterous Suction Cutter	Concept, Inc.	HKP	Class II	1977-01-05
K761345	Gluco-Hex Tm Reagent Kit	J.T. Baker Chemical Co.	CFR	Class II	1977-01-05
K761344	Dynazyme-II Tm Ck-230 Kit	J.T. Baker Chemical Co.	CGS	Class II	1977-01-05
K761343	Dynazyme-II Tm Ldh-L 340 Kit	J.T. Baker Chemical Co.	CFJ	Class II	1977-01-05
K761339	Radial Travel Spec. Procedures Table	Xre Corp.	IZZ	Class II	1977-01-05
K761336	Band-Aid Brand Plastic Bandages	Johnson & Johnson Professionals, Inc.	KGX	Class I	1977-01-05
K761335	Band-Aid Brand Sheer Bandages	Johnson & Johnson Professionals, Inc.	KGX	Class I	1977-01-05
K761324	Resurface Prostheses for Hip Joint	Holco Instrument Corp.	KXA	Class II	1977-01-05
K761302	Electronic Blood Pressure Unit	MEDLINE INDUSTRIES, LP - Northfield	DXN	Class II	1977-01-05
K761301	V-Trace ECG Backpad	Ndm Corp.	DRX	Class II	1977-01-05
K761278	Total Tibial Knee	Depuy, Inc.	HRY	Class II	1977-01-05
K761274	Blood Pressure Kit, Well-Be 669	Pearlduck, Inc.	DXN	Class II	1977-01-05
K761180	Sigmoidoscope/ Disposable	Smithkline Diagnostics, Inc.	FAM	Class II	1977-01-05
K761142	Headlights W/ Filter-Optico Cables	Pilling Co.	FST	Class II	1977-01-05
K761049	Kenatron Epilator	Epilator Corp.	KCX	Class I	1977-01-05