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 3367 of 3526

510(k) clearances, page 3367 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K800291	Endex Reamers Pulp Canal, Endodontic	Ipco Corp.	EKP	Class I	1980-02-19
K800275	Cebotome Drill	American Sterilizer Co.	HSZ	Class I	1980-02-19
K800274	Acufex Probes	Acufex Microsurgical, Inc.	HXB	Class I	1980-02-19
K800273	Acufex Forceps	Acufex Microsurgical, Inc.	HTD	Class I	1980-02-19
K800249	Surgitek Foerster Mammary Bandage	Medical Engineering Corp.	FRL	Class I	1980-02-19
K800248	Surgitek Foerster Face Lift Bandage	Medical Engineering Corp.	FRL	Class I	1980-02-19
K800212	Complement C3 Reagent System	Calbiochem-Behring Corp.	CZW	Class II	1980-02-19
K800211	Immunoglobulin a Reagent System	Calbiochem-Behring Corp.	CZP	Class II	1980-02-19
K800152	Surgikos Neutralon Br. Surgeon's Glove	Surgikos, Inc.	KGO	Class I	1980-02-19
K800144	Femoral Cement Restrictor	Zimmer GmbH	JDS	Class II	1980-02-19
K800143	Dynamic Extensor Splint	Zimmer GmbH	ILH	Class I	1980-02-19
K800142	Fuson Bone Plug, Radiopaque	Zimmer GmbH	JDS	Class II	1980-02-19
K792721	Huestis Flexi-Holder	Huestis Machine Corp.	IXA	Class II	1980-02-19
K792661	Treadmill Model 3060	Cambridge Instruments, Inc.	IOL	Class I	1980-02-19
K792500	Uvb Light Box - Uvb Light Booth	Sun Shanty, Inc.	FTC	Class II	1980-02-19
K791766	Echo-Oculometer #3000	JEDMED Instrument Company	IYO	Class II	1980-02-19
K791523	Visalens All Purpose Solution for Lens	Pfizer Inc	HPX	Unclassified	1980-02-19
K800240	Serocluster U and V	Corning Costar Corp.	JTC	Class I	1980-02-13
K800215	Culturia Macconkey/cled #Dm87	Clinical Convenience Products, Inc.	JXA	Class I	1980-02-13
K800190	Stanbio Direct Uric Acid Test Set #0770	Stanbio Laboratory	CDH	Class I	1980-02-13
K800189	Bovine Albumin 22% & 30% Solutions	Gotham Biologics, Inc.	KSG	Class II	1980-02-13
K800188	Emc-M-180, T3 Uptake - 100 Tubes	Endocrine-Metabolic Center	KHQ	Class II	1980-02-13
K800187	Emc-M-175, Thyroxine - 100 Tubes	Endocrine-Metabolic Center	CDX	Class II	1980-02-13
K800174	Gambro Lundia Coil Dialyzer	Gambro, Inc.	FHS	Class II	1980-02-13
K800170	Ames Rialyze - Uptake Chrom. Tubes	Miles Laboratories, Inc.	KHQ	Class II	1980-02-13
K800169	Ames Rialyze - Chromatography Tubes	Miles Laboratories, Inc.	CDX	Class II	1980-02-13
K800165	Ventre/sep T3 Uptake Radioassay	Ventrex Laboratories, Inc.	KHQ	Class II	1980-02-13
K800158	Azide Blood Agar Base W/&wthot Shp. Bld	Isle Media and Sterile Products, Inc.	JSJ	Class I	1980-02-13
K800157	Bismuth Sulfite Agar	Isle Media and Sterile Products, Inc.	JSI	Class I	1980-02-13
K800156	Staphylococcus Med. 110	Isle Media and Sterile Products, Inc.	JSJ	Class I	1980-02-13
K800141	Accustroke Pipet	Beckman Instruments, Inc.	JQW	Class I	1980-02-13
K800138	Ts-301 Three-Way Pulp Tester	Tamler-Stoneham Instruments	EAT	Class II	1980-02-13
K800130	Centrifichem Uric Acid	Union Carbide Corp.	CDO	Class I	1980-02-13
K800129	Centrifichem Creatinine	Union Carbide Corp.	CEX	Class II	1980-02-13
K800128	Centrifichem Bun	Union Carbide Corp.	CDQ	Class II	1980-02-13
K800127	Centrifichem Ck	Union Carbide Corp.	CGS	Class II	1980-02-13
K800126	Rsl (125 L) Progesterone Kit	Radioassay Systems Laboratories, Inc.	JLS	Class I	1980-02-13
K800123	Dextex II Sterilization Wrap	Ahlstrom Dexter	FRG	Class II	1980-02-13
K800120	Ldh (L-P) Reagent	Gilford Diagnostics	CFJ	Class II	1980-02-13
K800116	Durazyme Got/ast	American Monitor Corp.	CIT	Class II	1980-02-13
K800115	Durazyme Gpt/alt	American Monitor Corp.	CKA	Class I	1980-02-13
K800111	CO2 Content	American Monitor Corp.	CIL	Class II	1980-02-13
K800107	Follicle Stimulating Hormone	Radioimmunoassay, Inc.	CGJ	Class I	1980-02-13
K800106	Luteinizing Hormone Radioimmunoassay Sys	Radioimmunoassay, Inc.	CEP	Class I	1980-02-13
K800085	System 203 Chemistry Analyzer	Gilford Instrument Laboratories, Inc.	JJE	Class I	1980-02-13
K800075	Micromedic Punch & Eluter	Micromedic Systems	JQW	Class I	1980-02-13
K792606	Whole Blood Platelet Control Normal,	Dade, Baxter Travenol Diagnostics, Inc.	JPK	Class II	1980-02-13
K792460	Calbiochem-Behring Ria-Count	Calbiochem-Behring Corp.	CDD	Class II	1980-02-13
K792373	Ipco M-101 Echocardiograph (Ipco Ultra-	Ipco Corp.	DXK	Class II	1980-02-13
K800207	Uhr Universal6hip Replacement	Osteonics Corp.	KWL	Class II	1980-02-11