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 3514 of 3526

510(k) clearances, page 3514 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K760700	Silastic Brand G7-2090A	Dow Corning Corp. Healthcare Industries Materials	GCY	Class I	1976-11-02
K760697	Evans Arm and Hand Rest	Alcon Laboratories	HRK	Class I	1976-11-02
K760579	Instrument Rack for Dawson-Yuhl Instr.	V. Mueller O.V. Baxter Healthcare Corp.	FSM	Class I	1976-11-02
K760562	Chin Implants	Mediplast Laboratories, Inc.	FWP	Class II	1976-11-02
K760524	Catheter Connector, Argyle Tubing	Sherwood Medical Industries	GCD	Class I	1976-11-02
K760498	Tray, Disposable	Argon Medical Corp.			1976-11-02
K760456	Table, Hand Surgi	Stryker Corp.	FWZ	Class I	1976-11-02
K760428	Suture Rack & Needle Counter	Kleen Test Products Corporation	FSM	Class I	1976-11-02
K760424	Liquid Scintillation Counter	Beckman Instruments, Inc.	JJJ	Class I	1976-11-02
K760412	Ldh Substrate	J.T. Baker Chemical Co.	CFJ	Class II	1976-11-02
K760409	Sodium Nitrite	J.T. Baker Chemical Co.	CIG	Class II	1976-11-02
K760408	Potassium Sodium Tartrate	J.T. Baker Chemical Co.	CIG	Class II	1976-11-02
K760392	Syringes	B. Braun Instruments	FMF	Class II	1976-11-02
K760391	Catheter, Vein (Braunula)	B. Braun Instruments	JCY	Class I	1976-11-02
K760390	Catheter, Vein (Braunula T)	B. Braun Instruments	JCY	Class I	1976-11-02
K760389	Cannula, IV	B. Braun Instruments	FGY	Class I	1976-11-02
K760388	Catheter, Vein (Venofix)	B. Braun Instruments	DQO	Class II	1976-11-02
K760387	Catheter, Cava (Cavafix)	B. Braun Instruments	DQO	Class II	1976-11-02
K760386	Central Veinous Pressure Sets	B. Braun Instruments	DQO	Class II	1976-11-02
K760385	Extension Sets	B. Braun Instruments	KGZ	Class I	1976-11-02
K760384	Stoppers	B. Braun Instruments	KGZ	Class I	1976-11-02
K760383	Stopcocks	B. Braun Instruments	KGZ	Class I	1976-11-02
K760382	Connectors	B. Braun Instruments	GCD	Class I	1976-11-02
K760381	Blood Transfusion Set (Sangofix)	B. Braun Instruments	JCY	Class I	1976-11-02
K760380	Intravenous Transfer Set (Intrafix)	B. Braun Instruments	JCY	Class I	1976-11-02
K760870	Heel/elbow Flotation Cushion	Medpro, Inc.	FMP	Class I	1976-11-01
K760869	Split Cervical Collar/head Halter	Orthopedic Equipment Co., Inc.	HSS	Class I	1976-11-01
K760868	Vest Restraint	Orthopedic Equipment Co., Inc.	KNW	Class II	1976-11-01
K760866	Concha-Column	Respiratory Care, Inc.	BTT	Class II	1976-11-01
K760841	Hexcelite Sheet Splints	Hexcel Medical	ITG	Class I	1976-11-01
K760836	Negative Control Serum	I M, Inc.			1976-11-01
K760835	Anti-Aspergillus Cont. Ser. (Mycelial)	I M, Inc.	KFG	Class I	1976-11-01
K760834	Anti-Coccidioides Cont. Ser. (Mycelial)	I M, Inc.	GMH	Class II	1976-11-01
K760833	Anti-Blastomyces Control Serum (Yeast)	I M, Inc.	KFH	Class II	1976-11-01
K760832	Anti-Histoplasma Control Serum (Yeast)	I M, Inc.	GMK	Class II	1976-11-01
K760831	Anti-Histoplasma Control Serum(mycelial)	I M, Inc.	GMK	Class II	1976-11-01
K760830	Aspergillus Mycelial Antigen	I M, Inc.	JWT	Class I	1976-11-01
K760829	Coccidioides Mycelial Antigen	I M, Inc.	GMG	Class II	1976-11-01
K760828	Blastomyces Yeast Antigen	I M, Inc.	JJJ	Class I	1976-11-01
K760827	Histoplasma Yeast Antigen	I M, Inc.	GMJ	Class II	1976-11-01
K760826	Histoplasma Mycelial Antigen	I M, Inc.	GMJ	Class II	1976-11-01
K760801	Tsh Ria Kit	Siemens Healthcare Diagnostics Inc.	JLW	Class II	1976-11-01
K760800	Spac Digoxin Kit	Mallinckrodt Critical Care	DON	Class II	1976-11-01
K760785	Mishler 2 Chamb Flushing Valve,anti-Syph	Heyer Schulte Corp.	JXG	Class II	1976-11-01
K760784	Mishler 2 Chamb Flushing Valve,stand	Heyer Schulte Corp.	JXG	Class II	1976-11-01
K760775	Terumo Disposable Spinal Needle	Terumo America, Inc.	GAA	Class I	1976-11-01
K760748	Reagents for Blood Gas Instrumentation	Alko Scientific Co.	CHL	Class II	1976-11-01
K760747	Yasargil Suction Tube - Medium	Cerenovus, Inc.	GCY	Class I	1976-11-01
K760746	Yasargil Suction Tube - Large	Cerenovus, Inc.	GCY	Class I	1976-11-01
K760745	Yasargil Suction Tube - Small	Cerenovus, Inc.	GCY	Class I	1976-11-01