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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2786 of 3530

510(k) clearances, page 2786 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K873523	Plain Dry Gauze	Absorbent Cotton Co., Inc.	EFQ	Unclassified	1987-10-09
K873492	Bsk-1033 Telemetry Monitoring Cable	Desco Industries, Inc.	DSA	Class II	1987-10-09
K873477	Intermittent Signal Actuated Nebulizer (Visan)	Vortran Medical Technology 1, Inc	CCQ	Class I	1987-10-09
K873421	Kawasumi A.v. Fistula Set	Kawasumi Laboratories Co., Ltd.	FKQ	Class II	1987-10-09
K873416	Multi-Access Reagent Dispenser	Electro-Nucleonics Laboratories, Inc.	JQW	Class I	1987-10-09
K873355	Medix Biotech Prolactin Enzyme Immuno. Test Kit	Medix Biotech, Inc.	CFT	Class I	1987-10-09
K873337	Model Ssr1 Holter Monitor	Cardiodata Corp.	DSH	Class II	1987-10-09
K873280	Enhance Support Hose	Kimberly-Clark Corporation	DWL	Class II	1987-10-09
K873181	Stretcher, Wheeled, Mechanical	Cambridge Technologies, Inc.	FPO	Class II	1987-10-09
K873111	Conforma(tm) Plaster Bandages	The Kendal Co.	ITG	Class I	1987-10-09
K872954	Model Number 9216 Respiration/heart Rate Monitor	Aequitron Medical, Inc.	BZQ	Class II	1987-10-09
K872927	Davol Intraoperative Autotransfusion Kit	C.R. Bard Inc	CAC	Class II	1987-10-09
K872924	Paragon 8500 Cardio-Pulmonary Bed	Surgi-Med, Inc.	FNL	Class II	1987-10-09
K872805	Novolinpen Dial-a-Dose Insulin Delivery System	Squibb-Novo, Inc.	FMF	Class II	1987-10-09
K872793	Dp-700 Nikman Defib-Pads	Nikomed U.S.A., Inc.	LDD	Class II	1987-10-09
K872784	Mactrode-II	Marquette Electronics, Inc.	DRX	Class II	1987-10-09
K872771	Low Profile Gastrostomy	Microvasive	KNT	Class II	1987-10-09
K872743	Baxa Tubing Sets (for Pharmacy Pump)	Baxa Corp., Sub. of Cook Group, Inc.	FMF	Class II	1987-10-09
K872622	Orthodontic Arch	Wonder Wire	EJZ	Class I	1987-10-09
K872524	Safeweigh Magic Scale	Health Care Innovations, Inc.	FRW	Class I	1987-10-09
K872231	Bard Epicardial Electrode Array	C.R. Bard Inc	DRF	Class II	1987-10-09
K872123	Churchill Tpn Administration Set	Churchill Corp.	FPA	Class II	1987-10-09
K871705	Low Air Loss Bed	Integrated Medical Equipment Co.	FNM	Class II	1987-10-09
K871178	Mtc XI Ul	Aragona Medical, Inc.	FMT	Class II	1987-10-09
K871177	Nth 101 Ul	Aragona Medical, Inc.	FMT	Class II	1987-10-09
K870200	Sutter Finger Joint Prosthesis	Sutter Biomedical, Inc.	KYJ	Class II	1987-10-09
K873827	Mycology W/cyclohexanide & Chloramphemicol (C&c)	Lakewood Biochemical Co., Inc.	JSJ	Class I	1987-10-08
K873648	Bahia Allergen Disc	Incstar Corp.	DHB	Class II	1987-10-08
K873646	Digiviewer	Digivision, Inc.	LLZ	Class II	1987-10-08
K873549	Pediatric Bellows	Draeger, Inc.	CBK	Class II	1987-10-08
K873483	Tsa 5% Sheep Blood (Sb)/levine Emb Agar #Z3020	Lakewood Biochemical Co., Inc.	JSG	Class I	1987-10-08
K873482	Tsa 5% Sheep Blood (Sb)/macconkey Agar #Z3033	Lakewood Biochemical Co., Inc.	JSG	Class I	1987-10-08
K873481	Hektoen Enteric (He) Agar/xld Agar Biplate #Z3016	Lakewood Biochemical Co., Inc.	JSI	Class I	1987-10-08
K873480	Tsa 5% Sheep Blood/emb Agar - Product #Z3023	Lakewood Biochemical Co., Inc.	JSG	Class I	1987-10-08
K873479	Col. Cna 5% Sb/macconkey Agar Biplate # Z3206	Lakewood Biochemical Co., Inc.	JSJ	Class I	1987-10-08
K873420	Globalcare(tens)	Oms Medico, Inc.	GZJ	Class II	1987-10-08
K873193	Phadebas Rast/phadezym Rast Allergen Discs	Pharmacia, Inc.	DHB	Class II	1987-10-08
K872734	Mammograph Mammographic X-Ray Device	Palomex Instrumentarium Corp.	IZH	Class II	1987-10-08
K871553	X-Caliber Model 1000 Bone Mineral Analyzer	Hologic, Inc.	KGI	Class II	1987-10-08
K873789	Qm300 Transferrin Antibody Pack	Kallestad Diag, A Div. of Erbamont, Inc.	DDG	Class II	1987-10-07
K873761	Multichem Alkaline Phosphatase (S0903)	Simmler Inc	CJE	Class II	1987-10-07
K873727	Pull-Apart Introducer (Sheath)	Quinton, Inc.	DYB	Class II	1987-10-07
K873676	Ige Immuno Response Test (Irt) Calibrator Unit	Incstar Corp.	DHB	Class II	1987-10-07
K873668	Medix Biotech Lh Enzyme Immunoassay Test Kit	Medix Biotech, Inc.	CEP	Class I	1987-10-07
K873573	Ciba Corning Magic Lite Ferritin	Ciba Corning Diagnostics Corp.	DBF	Class II	1987-10-07
K873539	Aca Urine Drugs of Abuse Control	E.I. Dupont de Nemours & Co., Inc.	DIF	Class I	1987-10-07
K873488	Silent Guard Cat. No. Sg-10	American Omni Medical, Inc.	DTL	Class II	1987-10-07
K873486	Red Top Allergen Disc	Incstar Corp.	DHB	Class II	1987-10-07
K873474	Sutureless Temporary Epicardial Pacing Lead	Symbion, Inc.	LDF	Class II	1987-10-07
K873346	Model 2240 Slave Scope	Marquette Electronics, Inc.	DPS	Class II	1987-10-07