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 3481 of 3526

510(k) clearances, page 3481 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K771326	Nimetic Bonding Material	Espe GmbH (US)	KLE	Class II	1977-08-02
K771325	Nimetic Etching Gel	Espe GmbH (US)	KLE	Class II	1977-08-02
K771302	Pfister-Schwartz Stone Retriever	V. Mueller O.V. Baxter Healthcare Corp.	FGO	Class II	1977-08-02
K771266	Steam Sterilizer	Amsco Hospital Products Co.	ECG	Class I	1977-08-02
K771264	Flotation Therapy Bed	Aquarius Medical Services	IOQ	Class II	1977-08-02
K771239	Goat Lambda-Light Chain Antihuman Serum	G.D. Searle and Co.			1977-08-02
K771237	Nerve Stimulators	Rule Medical Instruments, Inc.	BXN	Class II	1977-08-02
K771229	Sterilizers, 3100 Series Trim Line	Castle Co.	FLE	Class II	1977-08-02
K771228	Lifecare Empty Container	Abbott Medical	KPE	Class II	1977-08-02
K771227	Ak-10	Gambro, Inc.	FIL	Class II	1977-08-02
K771198	Lumi-Aggregometer	Chrono-Log Corp.	JBY	Class II	1977-08-02
K771175	Resuscitator, Ms30	Mckesson Corp.	BTM	Class II	1977-08-02
K771156	Monitor, Liq. Chromatography Lc-15 UV	Revvity Health Sciences, Inc.	KIE	Class I	1977-08-02
K771125	Polyurethane Prod. for i.v. Needles	Devon Industries, Inc.	FPX	Class I	1977-08-02
K770991	Serum Glutamic Pyruvic Transaminase	Macomb Chemical Co.	CKA	Class I	1977-08-02
K770950	Whole Blood Gas Control	Dade, Baxter Travenol Diagnostics, Inc.	JJS	Class I	1977-08-02
K771357	Group Auditory Trainer Hc 431R	Hc Electronics	EPF	Class II	1977-07-29
K771356	Post-Auricular Hearing Aid Hc 880	Hc Electronics	ESD	Class I	1977-07-29
K771108	Needle, Chiba University	Johannah Medical Services, Inc.	FCG	Class II	1977-07-29
K770983	Catheter Thoracic, Axiom	Axiom Medical, Inc.	JOL	Class II	1977-07-29
K771344	Gusberg Hysterectomy Clamp	J. Sklar Mfg. Co., Inc.	HGC	Class I	1977-07-27
K771149	Endometrial Aspiration Biospy Kit 182341	C.R. Bard Inc	HHK	Class II	1977-07-27
K770944	Instatemp	H.I. Silverman, D.Sc.	KDP	Class II	1977-07-27
K771209	Terufusion Blood Admin. Set	Terumo America, Inc.	FMI	Class II	1977-07-26
K771199	Surgipulse Heart Rate Monitor	Stryker Corp.	DRT	Class II	1977-07-25
K771288	Jamar Dynamometeo Bk-7498	Fred Sammons, Inc.	HRW	Class I	1977-07-21
K771287	Fingeo Extension Splints	Fred Sammons, Inc.	IQM	Class I	1977-07-21
K771274	Quadriplegic Meat Knife	Fred Sammons, Inc.	ILC	Class I	1977-07-21
K771262	Pacemaker & Cardiac Lead, Bipolar	Arco Medical Products Co.	DXY	Class III	1977-07-21
K771226	Las-R Test Program	Hyland Therapeutic Div., Travenol Laboratories	CFN	Class II	1977-07-21
K771216	Centrifichem Triglyceoide Cali, Std. Set	Union Carbide Corp.	JIT	Class II	1977-07-21
K771215	Centrifichem Triglyceride Cali. Std.	Union Carbide Corp.	JIT	Class II	1977-07-21
K771202	Walpeo Tablh	Walpeo Corp.	INQ	Class I	1977-07-21
K771200	Orthoscope	Stryker Corp.	HRX	Class II	1977-07-21
K771157	Rm VI-Hv	Rich-Mar Corp.	IMG	Class II	1977-07-21
K771154	Cpk-Int Test	Hycel, Inc.			1977-07-21
K771131	Clinicard UV Amylase Chemistry	Harleco	JFJ	Class II	1977-07-21
K771101	Hemoglobin Analyzer & Perform. Check Set	The Dow Chemical Co.	GIG	Class II	1977-07-21
K771094	Unipak Albumin	Harleco	CIX	Class II	1977-07-21
K771093	Unipak Cholesterol	Harleco	CGO	Class I	1977-07-21
K771092	Unipak Total & Direct Bilirubin	Harleco	CIG	Class II	1977-07-21
K771091	Unipak Glucose	Harleco	CGE	Class II	1977-07-21
K771089	Unipak Total Bilirubin	Harleco	CIG	Class II	1977-07-21
K771088	Unipak Uric Acid	Harleco	KNK	Class I	1977-07-21
K771087	Unipak Bun	Harleco	CDW	Class II	1977-07-21
K771083	Sequential Pressure Cuff	Gaymar Industries, Inc.	JOW	Class II	1977-07-21
K771067	Cholesterol Kit	Environmental Chemical Specialties	CHH	Class I	1977-07-21
K771060	Diag. Conducta Rate Bun Reag. Set	J.T. Baker Chemical Co.	CDS	Class II	1977-07-21
K771059	Diag. Ozyrate Glucose Reag. Set	J.T. Baker Chemical Co.	CGA	Class II	1977-07-21
K770942	Phadecode Differential Factor Xa1 Assay	Pharmaseal Div., Baxter Healthcare Corp.	JBQ	Class II	1977-07-21