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 3219 of 3528

510(k) clearances, page 3219 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K821815	Advance C-Reactive Protein (Crp) Assay	Syva Co.			1982-06-25
K821806	Ortho Clg Immune Complex Test System	Ortho Diagnostic Systems, Inc.	DAK	Class II	1982-06-25
K821800	Regular Maxithins Pads & Super Maxithins	Tampax, Inc.	HHD	Class I	1982-06-25
K821771	Macro-Vue Card Test, Amikacin	BD Becton Dickinson Vacutainer Systems Preanalytic	KLQ	Class II	1982-06-25
K821767	Emit St Urine Methagualone Calibrator	Syva Co.	DKB	Class II	1982-06-25
K821760	Series M Push-Pull Input Compression	Maico Hearing Instruments, Inc.	ESD	Class I	1982-06-25
K821756	Iec Centra 4 Centrifuge	International Equipment Co.	JQC	Class I	1982-06-25
K821744	Fraser Harlake Nitronox Scavenger	Fraser Harlake, Inc.	CBN	Class II	1982-06-25
K821739	J. Morita Flex M-3 Torx Hardpiece	Pacific Dental Corp.	EKX	Class I	1982-06-25
K821720	Physiological Display System, Model 1000	Novametrix Medical Systems, Inc.	DRT	Class II	1982-06-25
K821715	Am-40 System	American Midwest	EFB	Class I	1982-06-25
K821710	Nagashima Nx-150F Light Source Unit	Kelleher Corp.	EQN	Class II	1982-06-25
K821709	Nagashima Light Source Unit Sl-5	Kelleher Corp.	EQN	Class II	1982-06-25
K821708	Nagashima Light Source Unit Sl-4	Kelleher Corp.	EQN	Class II	1982-06-25
K821707	Nagashima Sft-II Laryngoscope Straight	Kelleher Corp.	EQN	Class II	1982-06-25
K821706	Nagashima Sft-I Laryngoscope Right-Angl	Kelleher Corp.	EQN	Class II	1982-06-25
K821697	Injection Aspirating Needles	American Endoscopy, Inc.	GAA	Class I	1982-06-25
K821686	Densco Prophy Angle	Teledyne Densco	EGS	Class I	1982-06-25
K821660	Bio-Check Gram Stain Control	American Scientific Products	JTR	Class I	1982-06-25
K821658	Hemoglobin Reagent	Anco Medical Reagents & Assoc.	KHG	Class II	1982-06-25
K821587	Erika Hpf 50 Dialyzer	Erika, Inc.	FJI	Class II	1982-06-25
K821580	Fetal Monitor #Fm 750	Advantage Medical Systems, Inc.	HGM	Class II	1982-06-25
K821567	Immulok Cultureset	Immulok, Inc.	GQL	Class II	1982-06-25
K821554	Zetaphase T4 Radioimmunoassay Diag. Kit	Amf Biological and Diagnostics Co.	CDX	Class II	1982-06-25
K821553	Zetaphase T3 Uptake Diagnostic Kit	Amf Biological and Diagnostics Co.	KHQ	Class II	1982-06-25
K821479	Central Display System #Cs400	Advantage Medical Systems, Inc.	HGM	Class II	1982-06-25
K821475	Ultrachem E-Glu #64976&65040	EMD Millipore Corporation	CFR	Class II	1982-06-25
K821411	Histoset Immunoperofidase Tissue	Immulok, Inc.	GQL	Class II	1982-06-25
K821406	Arterial Blood Sampling Kit	Dhd Medical Products Div. Diemolding Corp.	CBT	Class I	1982-06-25
K821398	Corning Cpf 550 Lens	Corning Medical & Scientific	HQG	Class I	1982-06-25
K821186	Penetrak Tm	Syva Co.	GKZ	Class II	1982-06-25
K821063	Skin Markers	Devon Industries, Inc.	FZZ	Class I	1982-06-25
K820877	Automatic Objective Refractor 2000	Dicon, Inc.	HKO	Class I	1982-06-25
K820827	P105	Eurotan Intl.			1982-06-25
K820709	Airways	Seven Harvest Intl. Import & Export	CAE	Class I	1982-06-25
K820630	Quik-Sep Hemoglobin F Assay & Control	Isolab, Inc.	JPC	Class II	1982-06-25
K820256	Medilac #Sr4 & Sr 40	Spelna, Inc.	DSH	Class II	1982-06-25
K821796	Ez-Fix i.v. Catheter Holder	Dyna Care	KMK	Class I	1982-06-24
K821768	Emit St Urine Methagualone Assay	Syva Co.	KXS	Class II	1982-06-24
K821766	Emit - St Urine Methagualone Controls	Syva Co.	LAS	Class I	1982-06-24
K821754	A O Fiber Optic Illuminator, 1185B	Warner-Lambert Co.	FCR	Class II	1982-06-24
K821753	A O Fiber Optic Illumination, 1185A	Warner-Lambert Co.	FCR	Class II	1982-06-24
K821745	Bardex All Silicone Pediatric Catheter	C.R. Bard Inc	KOD	Class II	1982-06-24
K821725	T3 Diagnostic Kit Ria	Diagnostic Reagents, Inc.	CDP	Class II	1982-06-24
K821722	T3 Uptake Diagnostic Kit	Diagnostic Reagents, Inc.	KHQ	Class II	1982-06-24
K821719	Ammonia Reagent	Gilford Diagnostics	JIF	Class I	1982-06-24
K821704	Fracture Bracing	Hosmer Dorrance Corp.	IQI	Class I	1982-06-24
K821699	Deseret Subclavian Jugular Catheter Set	Warner-Lambert Co.	FOZ	Class II	1982-06-24
K821687	Removawell Tissue Culture Plate W/lid	Dynatech Corp.	KIZ	Class I	1982-06-24
K821684	Mcscp8ps with 'Y' Hub	Medical Components, Inc.	LFJ	Class II	1982-06-24