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 3204 of 3528

510(k) clearances, page 3204 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K822588	Advance Emit-Cad Quinidine Assay	Syva Co.	LBZ	Class II	1982-09-17
K822553	Pressure-Quet Tourniquet	Nutec Med, Inc.	GAX	Class I	1982-09-17
K822534	Needles(hypodermic)	Impex Laboratories	FMF	Class II	1982-09-17
K822533	Syringes(3-Parts Single Use)	Impex Laboratories	FMF	Class II	1982-09-17
K822532	Syringes(2-Parts Single Use)	Impex Laboratories	FMF	Class II	1982-09-17
K822504	Cdl Auto-Lysing Reagent	Connecticut Diagnostics, Ltd.	GGK	Class I	1982-09-17
K822501	Cdl Isotonic Diluent	Connecticut Diagnostics, Ltd.	GIF	Class I	1982-09-17
K822500	Cdl Lysing Reagent	Connecticut Diagnostics, Ltd.	GGK	Class I	1982-09-17
K822492	Optimized UV-Ldh Reagent Set	Biorent Diagnostic, Inc.	CFJ	Class II	1982-09-17
K822491	Disposable Grasping Forceps	Van-Tec, Inc.	GEN	Class I	1982-09-17
K822483	Multiple Scrub Suit	Surgilite Intl., Inc.	FXO	Class I	1982-09-17
K822481	Multiple Surgical Mask	Surgilite Intl., Inc.	FXX	Class II	1982-09-17
K822477	Creatinine Standard #65072	EMD Millipore Corporation	JIS	Class II	1982-09-17
K822473	Calcium Standard, Item #65075	EMD Millipore Corporation	JIS	Class II	1982-09-17
K822434	Crest Pressure Infusor	Crest Medical Equipment	KZD	Class I	1982-09-17
K822380	Rombeau Gastrostomy-Jejunal Tube	Hedeco	KNT	Class II	1982-09-17
K822284	Comply Neuromuscular Stimulator	Omega-Med Intl., Inc.	IPF	Class II	1982-09-17
K822204	ENT Mallets	Kelleher Corp.	GFJ	Class I	1982-09-17
K822626	Atc Bioelectrographic Monitor Model I.	Advantage Medical Systems, Inc.			1982-09-15
K821723	Bi-4520 Dual Impedometer	Farrall Instruments, Inc.			1982-09-15
K822655	Behind-the-Ear Model 115 V Agc O W	Danavox, Inc.	ESD	Class I	1982-09-14
K822642	Optilux & Visilux Dental Photo Lamp	Demetron Research Corp.	EBZ	Class II	1982-09-14
K822636	Class II Device for I.c.p. Monitoring	Philadelphia Medical Specialties	GWM	Class II	1982-09-14
K822632	Elbow Prosthesis	Hosmer Dorrance Corp.	IRE	Class I	1982-09-14
K822619	Behind-the-Ear Model 115Pppcw	Danavox, Inc.	ESD	Class I	1982-09-14
K822610	Precapsuled Dental Amalgam	Syntex Dental Products, Inc.	DZS	Class I	1982-09-14
K822603	Perma-Set Infusion Set	Cosmetic Sciences, Inc.	LDR	Class II	1982-09-14
K822568	Ear Probes	Kelleher Corp.	EKL	Class I	1982-09-14
K822566	Aural Reflex Indicator	Kelleher Corp.	ETY	Class II	1982-09-14
K822564	Water Bath	Boekel Industries, Inc.	JTQ	Class I	1982-09-14
K822563	Ophthalmic Microscope	Treace Medical, Inc.	HRM	Class I	1982-09-14
K822561	Microscope	Treace Medical, Inc.	EPT	Class I	1982-09-14
K822559	Sxt Blood Agar	Granite Diagnostics, Inc.	JSJ	Class I	1982-09-14
K822558	Lsm Agar	Granite Diagnostics, Inc.	JWX	Class I	1982-09-14
K822554	Cement Extraction Instrumentation	Surgi-Quip Inc.U			1982-09-14
K822552	Ny Fermentation Media	Gibco Laboratories Life Technologies, Inc.	JTY	Class II	1982-09-14
K822530	Multiple, ENT Chair #418	Midmark Corp	ETF	Class I	1982-09-14
K822517	Single Channel Nonfade Oscilloscope	Quinton, Inc.	DXJ	Class II	1982-09-14
K822515	B-Hcg Radioimmunoassay Kit	Bioclinical Group	JHI	Class II	1982-09-14
K822511	Yersinia Selective Supplement	Gibco Laboratories Life Technologies, Inc.	JSK	Class I	1982-09-14
K822507	Disposable Transducer & Accessories	Gould, Inc.	DRS	Class II	1982-09-14
K822490	Deflecting Cytology Brush	Van-Tec, Inc.	GEE	Class I	1982-09-14
K822479	Bilirubin Calibrator #65071	EMD Millipore Corporation	JIT	Class II	1982-09-14
K822478	Albumin Standard, #65070	EMD Millipore Corporation	JIT	Class II	1982-09-14
K822476	Phosphorous Standard #65073	EMD Millipore Corporation	JIS	Class II	1982-09-14
K822475	Total Protein Standard, #65074	EMD Millipore Corporation	JIT	Class II	1982-09-14
K822474	Cholesterol Standard #65077	EMD Millipore Corporation	JIS	Class II	1982-09-14
K822471	Psi Albumin Reagent	Horiba Instruments Incorporated	CIX	Class II	1982-09-14
K822470	Psi Inorganic Phosphorus	Horiba Instruments Incorporated	CEO	Class I	1982-09-14
K822469	Psi Calcium Reagent	Horiba Instruments Incorporated	CIC	Class II	1982-09-14