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 2026-11-02, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 2527 of 3531

510(k) clearances, page 2527 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K901872	Degufill (R) Etchant	Degussa AG	EBF	Class II	1990-08-01
K901856	Custom Wound Management Kits and Trays	Medcare Custom Packaging, Inc.	LRO	Class II	1990-08-01
K897180	Medi-Sure, Medi-Sorb	Gulf Coast Medical, Inc.	EFQ	Unclassified	1990-08-01
K894654	Flexhtr-1	Bird Products Corp.	BZE	Class II	1990-08-01
K903000	Turbo-Rast Specific Ige Assay	Ventrex Laboratories, Inc.	JHR	Class II	1990-07-31
K902919	Synermed Magnesium Reagent Kit	Synermed, Inc.	JGJ	Class I	1990-07-31
K902918	Synermed Serum Iron Reagent Kit	Synermed, Inc.	CFM	Class I	1990-07-31
K902857	Visi-Drape Ophthalmic Drapes	Visitec Co.	HMY	Class I	1990-07-31
K902793	Rubella Igg	Pharmacia Diagnostics, Inc.	LFX	Class II	1990-07-31
K902776	Spectrophotometer (Microassay Plate Readers)	Slt Labinstruments, Inc.	JJQ	Class I	1990-07-31
K902675	Multi Analyte Mixture, Calibrators	Phoenix Diagnostics, Inc.	JIX	Class II	1990-07-31
K902662	Bartels Herpes Simplex Vir Flu Mono Antibody Test	Baxter Healthcare Corporation	GQL	Class II	1990-07-31
K902661	Bartels Herpes Simplex Vir Flu Mono Antib Hsv-1&2	Baxter Healthcare Corporation	GQL	Class II	1990-07-31
K902407	Nf-50-E Disposable ECG Electrode	Medicotest, Inc.	DRX	Class II	1990-07-31
K902326	Amylase for Manual/automated Applications	Catachem, Inc.	JFJ	Class II	1990-07-31
K902270	Ciba Corning Magic Lite Chlamydia Immunoassay	Ciba Corning Diagnostics Corp.	LJC	Class I	1990-07-31
K902251	Subclavian Introducer Set	Infusaid Corp.	DYB	Class II	1990-07-31
K902202	Dma Triglyceride (Gpo) Procedure	Data Medical Associates, Inc.	JGY	Class I	1990-07-31
K902174	Coulter Hdl - Cholesterol Reagent	Coulter Corp.	LBR	Class I	1990-07-31
K902153	Teflon Coated Guidewire	Guidewire Technologies, Inc.	DQX	Class II	1990-07-31
K902152	Movable Core Guidewire	Guidewire Technologies, Inc.	DQX	Class II	1990-07-31
K901999	Fuji Lining Cement Light Cure	G-C Intl. Corp.	EJK	Class II	1990-07-31
K901994	Rosofsky & Ross Mouthspa Oral Care System	Rosofsky & Ross, Inc.	EFW	Class I	1990-07-31
K901252	Hewlett-Packard Series of Disposable Nibp Cuffs	Hewlett-Packard Co.	DXQ	Class II	1990-07-31
K901247	Tri Adapter W/adjustable Hemostasis Valves	Intec Medical, Inc.	DYG	Class II	1990-07-31
K901042	Ionometer Ef-Hk and Accessories	Fresenius USA, Inc.	JGS	Class II	1990-07-31
K900682	Phantom Radiotranslucent ECG Monitoring Electrode	Contour Electrodes, Inc.	DRY	Class II	1990-07-31
K900459	Applicard (EKG)	Medi-Globe GmbH	DRY	Class II	1990-07-31
K900207	Epicardia 4000	Medicomp, Inc.	DST	Class II	1990-07-31
K900112	Microring Yt	Medical Wire and Equipment Co. Ltd.	JXB	Class I	1990-07-31
K896985	Zap-Guard	Guardian Angel Products, Inc.	DRL	Class II	1990-07-31
K896807	Spbc Series Single Pass Blood Cardioplegia System	Gish Biomedical, Inc.	DTR	Class II	1990-07-31
K903273	Barbed Square Staple	Onyx Medical LLC	JDR	Class II	1990-07-30
K903271	Round Staple	Onyx Medical LLC	JDR	Class II	1990-07-30
K903270	T-Handle Hex Wrench	Onyx Medical LLC	LXH	Class I	1990-07-30
K903266	Steinman Pin, Thread	Onyx Medical LLC	JDW	Class II	1990-07-30
K903265	Steinman Pin	Onyx Medical LLC	HTY	Class II	1990-07-30
K903264	K-Wire	Onyx Medical LLC	HTY	Class II	1990-07-30
K903261	Rush Pin	Onyx Medical LLC	JDW	Class II	1990-07-30
K903257	Driver/extractor	Onyx Medical LLC	LXH	Class I	1990-07-30
K903256	Hansen-Street Type Intramedullary Nail	Onyx Medical LLC	HSB	Class II	1990-07-30
K903251	Jewett Hip Nail	Onyx Medical LLC	KTT	Class II	1990-07-30
K903250	Blade Plate	Onyx Medical LLC	KTT	Class II	1990-07-30
K903248	Combination Reamer	Onyx Medical LLC	HTO	Class I	1990-07-30
K903247	Adjustable Angle Guide	Onyx Medical LLC	LXH	Class I	1990-07-30
K903246	Side Plate	Onyx Medical LLC	KTT	Class II	1990-07-30
K903244	Lag Screw	Onyx Medical LLC	HWC	Class II	1990-07-30
K903243	Muller-Type Femoral Component	Onyx Medical LLC	JDI	Class II	1990-07-30
K903242	Acetabular Cup	Onyx Medical LLC	JDI	Class II	1990-07-30
K903241	Austin Moore Type Hip Prosthesis	Onyx Medical LLC	KWL	Class II	1990-07-30