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 2026-11-05, 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 2269 of 3531

510(k) clearances, page 2269 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K933001	Kodak Xml 300 Darkroom Film Feeder	Eastman Kodak Company	IXW	Class II	1993-09-28
K932860	Mayfield Adult Disposable Skull Pin	Ohio Medical Instrument Co., Inc.	HBL	Class II	1993-09-28
K932824	Evacuator, Oral Cavity	Den-Tal-Ez Mfg Co., Inc.	EIA	Class I	1993-09-28
K932807	Mayfield* a-2000 Skull Clamp	Ohio Medical Instrument Co., Inc.	HBL	Class II	1993-09-28
K932758	Medix Biotech Bestest Hcg-Urine Test Kit	Medix Biotech, Inc.	JHI	Class II	1993-09-28
K932536	Cardiometrics Flowire & Flomap	Cardio Metrics, Inc.	ITX	Class II	1993-09-28
K932408	Ambulatory Infusion Pump System and Solution Sets	Baxter Healthcare Corporation	FFN	Class I	1993-09-28
K931833	Modified Luer	Medi-Dyne, Inc.	DQO	Class II	1993-09-28
K931368	Microtainer Brand Tube with Edta	BD Becton Dickinson Vacutainer Systems Preanalytic	JKA	Class II	1993-09-28
K931201	Tri-Med Endoscopic Fluid Introduction Catheter	Tri-Med Specialties, Inc.	OCX	Class II	1993-09-28
K931025	Intherm Stasis Valve System	Interventional Therapeutics Corp.	FGE	Class II	1993-09-28
K930755	Ultra Compact Video Imager	International Imaging Electronics	LMC	Class II	1993-09-28
K926455	Pari Filter/valve Set	Paul Ritzau Pari-Werk GmbH	CAF	Class II	1993-09-28
K925420	Techmedica Standard Bipolar System	Techmedica, Inc.	KWY	Class II	1993-09-28
K925081	Surfas	D.O. Weaver Co.	ITX	Class II	1993-09-28
K924079	Cfm-800 Color Flow Mapping System	Diasonics, Inc.	IYO	Class II	1993-09-28
K923321	Edge Syringes and Needles	Trico Intl., Inc.	FMF	Class II	1993-09-28
K932463	Bioclot La	Biopool AB	GIR	Class I	1993-09-27
K932220	Lap Choly Trays (Packs)	Associated Medical Products Co.	LRO	Class II	1993-09-27
K932162	Uric Acid Test Item Number 65422	Em Diagnostic Systems, Inc.	CDO	Class I	1993-09-27
K932158	Calcium Test Item Number 65409	Em Diagnostic Systems, Inc.	CIC	Class II	1993-09-27
K931586	Vital-Port Mini Vascular Access System	Med Institute, Inc.	DWF	Class II	1993-09-27
K931177	Synelisa Cortisol	Elias U.S.A., Inc.	CGR	Class II	1993-09-27
K926446	Ez Pump	Alphamed, Inc.	FRW	Class I	1993-09-27
K925645	Selec-3	Biomedix Wai	FPA	Class II	1993-09-27
K925248	Modification of Intra-Aortic Balloon Catheters	Kontron Instruments, Inc.	DSP	Class II	1993-09-27
K924447	Vitapen	Vitajet Corp.	KZF	Class I	1993-09-27
K923506	Urea Kit	Randox Laboratories, Limited	CDQ	Class II	1993-09-27
K933744	Sas(tm) Hcg Urine Controls, Various Sizes	SA Scientific, Ltd	JJX	Class I	1993-09-24
K933648	Added Use Claim for Dupont Aca Beta-2-Microglobulin Test Pack	Dupont Medical Products	JZG	Class II	1993-09-24
K933483	Opti-Plast 5F Pta Catheters	Vas-Cath, Inc.	LIT	Class II	1993-09-24
K933435	Dade Urine Chemistry Control, Level 1 & Level 2	Baxter Diagnostics, Inc.	JJY	Class I	1993-09-24
K932882	Gc II Agar with Isovitalex	Becton Dickinson Microbiology Systems	JSO	Class II	1993-09-24
K932850	Enzyme Immonoassay Extractable Nuclear Antigen	Helix Diagnostics, Inc.	LLL	Class II	1993-09-24
K932685	Paramax(r) Theophylline Reagent and Calibrators	Baxter Diagnostics, Inc.	KLS	Class II	1993-09-24
K932267	Enzymatic CO2 Reagent, Modification	Intersect Systems, Inc.	KHS	Class II	1993-09-24
K932209	Toxi*lab Ltd Opiate System	Toxi-Lab, Inc.	LAI	Class II	1993-09-24
K932142	Suction Guillotine Device	Triton Technology, Inc.	FCK	Class II	1993-09-24
K931702	Immulite Beta-2-Microglobulin	Siemens Healthcare Diagnostics Inc.	JZG	Class II	1993-09-24
K931255	Synelisa Cenp-B Antibodies	Elias U.S.A., Inc.	LKJ	Class II	1993-09-24
K930928	Roche Abuscreen Online for Methadone	Roche Diagnostic Systems, Inc.	DJR	Class II	1993-09-24
K930758	Diagnostic Intravascular Catheter	Applied Medical Resources Corp	LYK	Class II	1993-09-24
K926108	Vingmed Sound Color Flow Mapping System, Cfm-800	Vingmed Sound, Inc.	ITX	Class II	1993-09-24
K925439	Microsnare	Microvena Corp.	DQY	Class II	1993-09-24
K922244	Insufflator Tubing/filter Kit	O.R. Concepts, Inc.	HIF	Class II	1993-09-24
K922197	Insufflator Tubing Kit	O.R. Concepts, Inc.	HIG	Class II	1993-09-24
K921957	Hewlett-Packard Model M1351a Fetal Monitor	Hewlett-Packard Co.	HGM	Class II	1993-09-24
K921956	Hewlett Packard Model M1353a Fetal Monitor	Hewlett-Packard Co.	HGM	Class II	1993-09-24
K933604	Qb II Blunt Dissector	Joyce M. Shotwell, M.D.	FGS	Class II	1993-09-23
K933333	Hgm Scanman Plus	Hgm, Inc.	GEX	Class II	1993-09-23