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 2026-10-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 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	2,502

176,299 records, page 3505 of 3526

510(k) clearances, page 3505 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K761034	Surgex Surgical Sponge	Convertors	EFQ	Unclassified	1977-01-05
K760931	i.v. Drip Monitor Alarm Device, Moniflo	Diemolding Corp.	FLN	Class II	1977-01-05
K760896	Barrier Orthopaedic Split Sheet	Surgikos, Inc.			1977-01-05
K760516	Felt, Surgical Dacron	Meadox Medicals, Div. Boston Scientific Corp.	DXZ	Class II	1977-01-05
K761355	Selfast	Septodont	EMA	Class II	1977-01-03
K761354	Cimpat (Pink and White)	Septodont	EMA	Class II	1977-01-03
K761352	Dental Stain Remover	Concept, Inc.	EFW	Class I	1977-01-03
K761331	Opus I Option - Fiber Optic L System	Syntex Corp.	EAY	Class I	1977-01-03
K761297	Mouthpiece Seal	Oem Medical Div.	BYP	Class I	1977-01-03
K761294	Respiratory Blower	Harris-Lake, Inc.	BTI	Class II	1977-01-03
K761293	Respiratory Humidifier	Harris-Lake, Inc.	BTT	Class II	1977-01-03
K761287	5M1352 Proport. Dialysis Fluid Deliv.ery	Travenol Laboratories, S.A.	FKP	Class II	1977-01-03
K761332	Hi-Sensitivity Mode Option for S60-1A	Syntex Corp.	JAK	Class II	1976-12-30
K761330	Syntex System 6000	Syntex Corp.	JAK	Class II	1976-12-30
K761311	Accraassay Rid Kits	Miles Laboratories, Inc.	JZQ	Class I	1976-12-30
K761309	Ob-Gyn Control Sera (Code 196300)	Amersham Corp.	JIX	Class II	1976-12-30
K761305	Centria T3 Ria	Union Carbide Corp.	CDP	Class II	1976-12-30
K761303	Immu-Sal Immunohematological Saline	Dade, Baxter Travenol Diagnostics, Inc.	KSS	Class I	1976-12-30
K761300	Nebulizer Control Unit	Mcgaw Respiratory Therapy	CAF	Class II	1976-12-30
K761299	Disposable Nebulizer	Mcgaw Respiratory Therapy	CAF	Class II	1976-12-30
K761298	Pre-Filled Disposable Nebulizer	Mcgaw Respiratory Therapy	CAF	Class II	1976-12-30
K761295	Resp. Air Temp. Control & Hazard Mon.	Harris-Lake, Inc.	BZE	Class II	1976-12-30
K761282	Data-Tope T4 Ria Procedure	Dade, Baxter Travenol Diagnostics, Inc.	CDX	Class II	1976-12-30
K761270	Immuno-Tec II Ot Agarose Plate Kit	Behring Diagnostics, Inc.	JZP	Class I	1976-12-30
K761267	Angiotensin I Immutope Kit	Squibb & Sons, Inc.	CIB	Class II	1976-12-30
K761241	Pre-Duced Surgi-Swab & Transporter Tube	Gibco Laboratories Life Technologies, Inc.	JTX	Class I	1976-12-30
K761236	Antiserum Human (Pro.) Nephelometric Gr.	Behring Diagnostics, Inc.	JZW	Class I	1976-12-30
K761235	Laser Standard Serum	Behring Diagnostics, Inc.	JZW	Class I	1976-12-30
K761071	P.s.m. Justa Kap	The Owenby Co.	FYF	Class I	1976-12-30
K761070	P.s.m. Surgical Hood	The Owenby Co.	FXY	Class II	1976-12-30
K761069	P.s.m. Botique Cap	The Owenby Co.	FYF	Class I	1976-12-30
K761068	P.s.m. Bouffant Cap	The Owenby Co.	FYF	Class I	1976-12-30
K761064	Coventry Staple	Depuy, Inc.	GDW	Class II	1976-12-30
K761051	Bi-Flow Needle	Dws, Inc.	KOC	Class II	1976-12-30
K761050	Heparin Pump	Dws, Inc.	FIR	Class II	1976-12-30
K760954	Crowntex Exam. Cape & Gown	Graham Manufacturing Co.	FME	Class I	1976-12-30
K760951	Devon Cool Face	Devon Industries, Inc.	KYR	Class I	1976-12-30
K760934	Hospitality Server	Plastics/Packaging			1976-12-30
K760917	Las-R Human Haptoglobin Test	Hyland Therapeutic Div., Travenol Laboratories	DFT	Class II	1976-12-30
K760909	Thermometer Jars and Caps	Plastics/Packaging	ELK	Class I	1976-12-30
K760904	Cleaning and Isolation Room Kit	American Hospital Supply	FYC	Class II	1976-12-30
K760880	Additive Cap (2B8905)	Travenol Laboratories, S.A.	KPE	Class II	1976-12-30
K760765	Whole Blood Platelet Counter -2510	Clay Adams, Div. Becton Dickinson & Co.	GKL	Class II	1976-12-30
K760699	Multi-Test	Lincoln Laboratories, Inc.	SCL	Class II	1976-12-30
K760662	Steril.wrap(#221901,2,3,4,5,6,7,8,9)	C.R. Bard Inc	FRG	Class II	1976-12-30
K761285	Pet-Scope	Diagnostic Information, Inc.	JAA	Class II	1976-12-29
K761269	Gemeni Gpt (Alt) Assay	Electro-Nucleonics Laboratories, Inc.	CKA	Class I	1976-12-29
K761263	Cholesterol Automated Reagent	Worthington Biochemical Corp.	CHH	Class I	1976-12-29
K761262	Triglycerides (Lipase) Reagent Set	Worthington Biochemical Corp.	CDT	Class I	1976-12-29
K761261	Enzymatic Bun (Rate) Reagent Kit	Beckman Instruments, Inc.	CDQ	Class II	1976-12-29