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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3190 of 3528

510(k) clearances, page 3190 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K823448	Implantable Pacing Lead Tined #3390 &	Oscor Inc.	DTB	Class III	1982-12-03
K823447	Implantable Pacing Lead, Tined #3262 &	Vascular Products, Inc.	DTB	Class III	1982-12-03
K823446	Products Implantable Pacing Lead,tined	Oscor Inc.	DTB	Class III	1982-12-03
K823443	Herpes Transette	Spectrum Diagnostic, Inc.	JTW	Class I	1982-12-03
K823442	Fisch Modified Total Ossicular Prosthes	Treace Medical, Inc.	LBM	Class II	1982-12-03
K823441	Austin Modified Total Ossicular Replace	Treace Medical, Inc.	LBM	Class II	1982-12-03
K823440	Mcgee Modified Stainless Steel Piston	Treace Medical, Inc.	ETB	Class II	1982-12-03
K823439	Causse Tef-Piston	Treace Medical, Inc.	ETB	Class II	1982-12-03
K823431	Hearing Aid #G6h & G6t	Widex Hearing Aid Co., Inc.	ESD	Class I	1982-12-03
K823429	Fisch Modified Tef-Wire Piston	Treace Medical, Inc.	ETB	Class II	1982-12-03
K823418	Heyer-Schute Universal Ureteral Stent	American Hospital Supply	LJE	Unclassified	1982-12-03
K823395	Traction-Steel Framing System	Mizuho Orthopedic Systems Inc	HST	Class I	1982-12-03
K823394	Walking Heel	Mizuho Orthopedic Systems Inc	LGF	Class I	1982-12-03
K823393	Stax Finger Splints	Mizuho Orthopedic Systems Inc	ILH	Class I	1982-12-03
K823378	Cera Color	Cer-Met, Inc.	EIH	Class II	1982-12-03
K823377	Cera 8	Cer-Met, Inc.	EIH	Class II	1982-12-03
K823372	Octagonal Aluminum Framing System	Mizuho Orthopedic Systems Inc	HST	Class I	1982-12-03
K823370	Advance Tm Emit(r) & Tm Amikacin Assay	Syva Co.	KJI	Class II	1982-12-03
K823360	Surgical Light	Amsco Co.	FTD	Class II	1982-12-03
K823356	Ready-Box Body-Temp Media Warmer Mallin-	Forma Scientific, Inc.	DXT	Class II	1982-12-03
K823350	Elastic Compression Anklet	Podiatry Products Corp.	FQL	Class I	1982-12-03
K823309	Martin & Lemis Agar W/vcat Inhibitor	Troy Biologicals, Inc.	JTY	Class II	1982-12-03
K823308	Mycarel Agar Mycobrotic Agar	Troy Biologicals, Inc.	JSJ	Class I	1982-12-03
K823301	Micropad	Fia Man Co.	IRT	Class II	1982-12-03
K823283	Flushing Solution	Nobel Scientific Industries, Inc.			1982-12-03
K823275	Autopak Ferritin Test Delivery Sys	Micromedic Systems	DBF	Class II	1982-12-03
K823248	Schaedler Agars	Granite Diagnostics, Inc.	JSJ	Class I	1982-12-03
K823240	Cap-Ria 16	Mirion Technologies (Capintec), Inc.	JJJ	Class I	1982-12-03
K823230	Sterile Water System	Syntex Dental Products, Inc.	EIA	Class I	1982-12-03
K823219	Liquizyme Calcium Reagent Set	American Research Products Co.	CIC	Class II	1982-12-03
K823195	Gastric Lavage Kit	Autovage	KNT	Class II	1982-12-03
K823184	Bipolar Coagulator #9620/9621	Concept, Inc.	GEI	Class II	1982-12-03
K823146	Calmset 3 Tm	Thought Technology Ltd.	HCC	Class II	1982-12-03
K823139	Smith's Medium	Granite Diagnostics, Inc.	JSJ	Class I	1982-12-03
K823137	Octapettes	Corning Costar Corp.	JTC	Class I	1982-12-03
K823122	Laked Blood Agar W/paromomycin & Vancom	Granite Diagnostics, Inc.	JSI	Class I	1982-12-03
K823115	Naturalyte Bicarbonate Dialysate 4400	Erika, Inc.	KRO	Class II	1982-12-03
K823102	Agar P	Dms Laboratories	JSJ	Class I	1982-12-03
K823095	Kinetic Motion Bed	Motion Manufacturers, Inc.	IKZ	Class II	1982-12-03
K823051	Metal Knee & Hip Prosthesis	Zimmer GmbH	KWL	Class II	1982-12-03
K822985	Ebv-M Kit	Litton Bionetics	JRY	Class I	1982-12-03
K822914	1424 Tumistore	Life-Tech Intl., Inc.			1982-12-03
K822867	Glyc-Affin Glycohemoglobin Assay	Isolab, Inc.	LCP	Class II	1982-12-03
K822826	Antibody to Mumps Virus Ifa Test	Electro-Nucleonics Laboratories, Inc.	GRA	Class I	1982-12-03
K822778	Blood Gas Exper. System 8700	Exper Corp., Inc.	JQP	Class I	1982-12-03
K822737	Mycotrium-Rs	Hana Biologics, Inc.	JSI	Class I	1982-12-03
K822736	Mycotrium-Gu	Hana Biologics, Inc.	JSI	Class I	1982-12-03
K822733	Sigma Reagent System No. 885	Sigma Chemical Co.	JBE	Class II	1982-12-03
K822682	Anti-Native (Double Standard) DNA Test K	Amico Lab, Inc.	DHN	Class II	1982-12-03
K822560	Irrigation Set	Utah Medical Products, Inc	NBH	Class I	1982-12-03