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 2026-10-19, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 3045 of 3529

510(k) clearances, page 3045 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K843701	Total Protein Reagent Set	Livonia Diagnostics, Inc.	CEK	Class II	1984-10-01
K843629	Fetal Bovine Serum, F4884 Sterile Growt	Sigma Chemical Co.	KIS	Class I	1984-10-01
K843571	Rim-Urea	Austin Biological Laboratories	JSS	Class I	1984-10-01
K843560	Bacto Staphylococcus Latex Test	Difco Laboratories, Inc.	JWX	Class I	1984-10-01
K843554	Bone Screws	Mecron Medical Products, Inc.	KTW	Class II	1984-10-01
K843553	Bone Plates	Mecron Medical Products, Inc.	KTW	Class II	1984-10-01
K843408	Encore Ige Reagent	Hybritech, Inc.	DGC	Class II	1984-10-01
K843388	Wellington Hospital Pattern Self-Retain	Downs Surgical, Ltd.	HDF	Class I	1984-10-01
K843286	Ei-Candida Enzyme Immunoassay Ei1001	IMMY, Inc.	LRF	Class II	1984-10-01
K843156	Biolas Yag 100 Cilas, Ercelas Yag 100	Advanced Biomedical Instruments	LNK	Class II	1984-10-01
K843154	Tooth Root Socket Gauge	Interpore Intl.	LYC	Class II	1984-10-01
K842982	Formalin Buffered	Reagent Laboratory, Inc.	IFP	Class I	1984-10-01
K842747	Hycel Dilutor, Various Models/multi	R & D Systems, Inc.	GKH	Class I	1984-10-01
K842658	Anti-Chlamydia Trachomatis Kit	Amico Lab, Inc.	LJP	Class I	1984-10-01
K842654	Epsilon Hcg Test Kit Monoclonal	Beckman Instruments, Inc.	JHI	Class II	1984-10-01
K842617	Vonwillebrand Factor Antigen Semi-Quant	American Dade	GGP	Class II	1984-10-01
K842537	Von Willebrand Factor Antigen Screen	American Dade	ICF	Class I	1984-10-01
K842525	Amizyme-C Trachomatis Test Kit	Amico Lab, Inc.	LJP	Class I	1984-10-01
K842504	Amer. Medical Optics Digital Kerato-	American Medical Optics	HQL	Class III	1984-10-01
K842398	Sur-Fit Irrigation Adapter Faceplate	Convatec, A Division of E.R. Squibb & Sons	EXB	Class I	1984-10-01
K842212	Micromedics Surgical Instruments	Micromedics, Inc.			1984-10-01
K842197	American Medical Optics I/a Kit- Irrig	American Medical Optics	HQE	Class II	1984-10-01
K842144	Gore-Tex Vascular Graft, Fep-Ringed	W. L. Gore & Associates, Inc.	DYF	Class II	1984-10-01
K842121	E-Z-Em Single Stick Puncture/drainage	E-Z-EM, Inc	LJE	Unclassified	1984-10-01
K843645	Systemate a Amylase Hem 67204	Em Diagnostic Systems, Inc.	CIJ	Class II	1984-09-28
K843635	Matched Component Set for Radioimmuno-	Cambridge Medical Technology	JKC	Class I	1984-09-28
K843621	Fiax 420 Dilutor	Intl. Diagnostic Technology	JQW	Class I	1984-09-28
K843611	Qualify I & II Amer. Monitor 2009 & 2010	American Monitor Corp.	JJY	Class I	1984-09-28
K843569	Preciset Ammonia	Boehringer Mannheim Corp.	JJX	Class I	1984-09-28
K843541	Pda Glucose	Abbott Medical	CFR	Class II	1984-09-28
K843528	Glucose Oxidase Enzymatic Reagent Set	Livonia Diagnostics, Inc.	CGA	Class II	1984-09-28
K843510	Pda Cholesterol	Abbott Medical	CHH	Class I	1984-09-28
K843508	Emit 700 Control Set B	Syva Co.	DIF	Class I	1984-09-28
K843384	Leeco Cortisol-Quant	Leeco Diagnostics, Inc.	CGR	Class II	1984-09-28
K843379	Vma Assay Kit	Diagnostic Chemicals, Ltd. (USA)	CDF	Class I	1984-09-28
K843377	Creatinine Assay Kit	Diagnostic Chemicals, Ltd. (USA)	CGX	Class II	1984-09-28
K843222	Enzymatic Cholesterol Kit	Livonia Diagnostics, Inc.	CHH	Class I	1984-09-28
K843003	Glucose Auto& Stat Ga-1120	Kyoto Diagnostics, Inc.	CGA	Class II	1984-09-28
K842755	Titan Gel ISO Dot Cpk Procedure	Helena Laboratories, Corp.	CGS	Class II	1984-09-28
K842018	ISO-Sep System	Berwick Medical Products, Inc.	CEX	Class II	1984-09-28
K834474	H.p.t. Home Preg. Test Kit & A.p.t.	Biomedical Research & Development Laboratories, Inc.	LCX	Class II	1984-09-28
K843718	Programmable Stimulator 5326	Medtronic, Inc.	JOQ	Class II	1984-09-27
K843509	Emit 700 Phencyclidine Assay	Syva Co.	LCM	Unclassified	1984-09-27
K843452	Standard & Solutions for Nova 4 Analyz	Fisher Scientific Company L.L.C.	JGS	Class II	1984-09-27
K843436	Dental Chair	Swedish Dental Products, Inc.	KLC	Class I	1984-09-27
K843428	Biofix	Accra Laboratories, Inc.	LDZ	Class I	1984-09-27
K843426	Eosin Y 1% Alcoholic	Accra Laboratories, Inc.	HYB	Class I	1984-09-27
K843365	ISO-Data Immunoassay Network System	Iso-Data, Inc.	JQP	Class I	1984-09-27
K843359	Urine Transport Kit	Applied Polytechnology, Inc.	JTW	Class I	1984-09-27
K843341	Gono-Pak W/thayer-Martin Agar/gono-Pak	BD Becton Dickinson Vacutainer Systems Preanalytic	JTW	Class I	1984-09-27