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 3034 of 3529

510(k) clearances, page 3034 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K843096	Cristy/cote	Titmus Optical, Inc.	HQG	Class I	1984-11-21
K843041	Heslin Dispos. Tubing Set	Innovative Surgical Products, Inc.	HQE	Class II	1984-11-21
K843039	Site Anterior Capsulotomer	Chiron Vision Corp.	HMX	Class I	1984-11-21
K842835	Brillette Model	Cillus Company, Inc.	HOI	Class I	1984-11-21
K842471	Automated Intraocular Scissors	Medical Instrument Development Laboratories, Inc.	HQE	Class II	1984-11-21
K842420	Norta Siliconized Latex Balloon Cath.	Beiersdorf, Inc.	KOD	Class II	1984-11-21
K841807	Operaid Nucleus	JEDMED Instrument Company	KYG	Class I	1984-11-21
K841721	Operaid Surgical Drain	JEDMED Instrument Company	HOZ	Class II	1984-11-21
K844333	Spirometrics 2451 & Smi I	Spirometrics, Inc.	BZG	Class II	1984-11-20
K844237	Alkaline Phosphatase Reagent Set	Livonia Diagnostics, Inc.	CIO	Class II	1984-11-20
K844235	Chloride Standard	Shaban Mfg. Co.	JIS	Class II	1984-11-20
K844226	B-1000	Biotrine Corp.	BZG	Class II	1984-11-20
K844168	Amylase Reagent Cs-726	Fisher Scientific Company L.L.C.	CJA	Class II	1984-11-20
K844148	Pin Cutter	Med-Tool, Inc.			1984-11-20
K844147	Wire Twisters	Med-Tool, Inc.			1984-11-20
K844146	Toggle Locking Pliers-Straight Jaw, Curved Jaw	Med-Tool, Inc.	HTC	Class I	1984-11-20
K844145	General Surgical Files	Med-Tool, Inc.	GEO	Class I	1984-11-20
K844030	Accumeter Electronic Urinemeter System	Travenol Laboratories, S.A.	FFG	Class II	1984-11-20
K844022	Elecath Ventricular Pacing Thermal Dilution Cath	Electro-Catheter Corp.	DXG	Class II	1984-11-20
K843996	Turboaire Challanger Environmental Air Controller	Equilibrated Bio Systems, Inc.	BZG	Class II	1984-11-20
K843975	9 French 42Long Polyurethane Graduated Enteric Fe	Superior Plastic Products Corp.	KNT	Class II	1984-11-20
K843934	Model {M-102 I-Channel Electro Cardiograph Unit	Future Impex Corp.	DPS	Class II	1984-11-20
K843568	Liquid Chromatograph 400	Revvity Health Sciences, Inc.	KZR	Class I	1984-11-20
K843464	Siegen Neuroscope	Siegen Corp.	GWF	Class II	1984-11-20
K843412	Flow Directed Thermodilution Cath W/ven	Andover Medical, Inc.	KRB	Class II	1984-11-20
K843410	Flow-Directed Pediatric Thermodil- Cath	Andover Medical, Inc.	KRB	Class II	1984-11-20
K843253	Emg/ncv & Evoked Response, Design W/	Neurodiagnostics, Inc.	GWF	Class II	1984-11-20
K843076	Suction Catheter Kit	Travenol Laboratories, S.A.	BSY	Class I	1984-11-20
K840899	Servomed Arrhycomp Central Monitor Sys	Litton Medical Electronics	DSI	Class II	1984-11-20
K840439	Recomed Cardiac Output Meter 236067-	Litton Medical Electronics	DXG	Class II	1984-11-20
K844289	Series I/s Infections	American Dade	KTN	Class II	1984-11-19
K844286	Flash Guard Plastic Version	Sparco, Inc.	FSM	Class I	1984-11-19
K844239	Nec-Kradle by Vencor	Vencor	HST	Class I	1984-11-19
K844158	Stratus Ferritin Fluorometric Enzyme Immunoassay	American Dade	DBF	Class II	1984-11-19
K844110	Xtraceteze Surgical Skin Staple Remover 2001	Pelco, Inc.	PYE	Class I	1984-11-19
K844096	Wet Dressing Saline-Sterile	Absorbent Cotton Co., Inc.	FRO	Unclassified	1984-11-19
K844073	Seeram Blade	Seeram Products Development			1984-11-19
K844063	Scissors General Hospital	I M, Inc.			1984-11-19
K843469	Pharma-Plast Suction Tip, Type Orthopae-	Zimmar Consulting, Ltd.	JOL	Class II	1984-11-19
K843467	Pharma-Plast Nasal Oxygen Cannula	Zimmar Consulting, Ltd.	CAT	Class I	1984-11-19
K843466	Pharma-Plast Oxygen Catheter	Zimmar Consulting, Ltd.	BZB	Class I	1984-11-19
K843451	Factor XII Deficient Plasma B12d	Sigma Chemical Co.	GGP	Class II	1984-11-19
K843438	Factor XI Deficient Plasma B11d	Sigma Chemical Co.	GGP	Class II	1984-11-19
K843358	Heart-Aid Model 80	Cardiac Resucitator Corp.	DRO	Class II	1984-11-19
K843354	Episcleral Venous Pressure	Eyetech, LLC	HKX	Class II	1984-11-19
K843342	Lenskeeper Lens Carrying Case	Allergan Pharmaceuticals, Inc.	HPX	Unclassified	1984-11-19
K843310	Factor X Deficient Plasma, Blod Human	Sigma Chemical Co.	GGP	Class II	1984-11-19
K843215	Factor IX Deficient Plasma, B9d -	Sigma Chemical Co.	GGP	Class II	1984-11-19
K842715	Documentor	Life Technology	DSI	Class II	1984-11-19
K842465	Uniloc	American Ortomed Corp.	KWL	Class II	1984-11-19