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 2026-10-12, 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 3270 of 3528

510(k) clearances, page 3270 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K811741	Cell-Chex Rbc	Streck Laboratories, Inc.	KRX	Class II	1981-09-24
K811706	Lactic Acid Dialysate Additive	Edlaw Pharmaceuticals, Inc.	KPO	Class II	1981-09-24
K812600	Ger 540, Ger 541 Manual Bed	G.W. Healthcare, Inc.	FNJ	Class I	1981-09-23
K812582	Cancel	Bio Systems, Inc.	EXB	Class I	1981-09-23
K812581	Sensi-Tect	Uti-Tect, Inc.	JTZ	Class II	1981-09-23
K812580	Medtronic Model 2409	Medtronic, Inc.	DXY	Class III	1981-09-23
K812553	Aqueous Blood Gas Controls	Fisher Scientific Company L.L.C.	JJS	Class I	1981-09-23
K812552	Corometrics Medical Syst. 220 Ph Analy.	Transidyne General Corp.	CHL	Class II	1981-09-23
K812551	Beaucor	Sci-Pharm, Inc.	EBF	Class II	1981-09-23
K812547	Beaubon	Sci-Pharm, Inc.	DYH	Class II	1981-09-23
K812541	Protein-Based Blood Gas Control	American Dade	JJS	Class I	1981-09-23
K812536	Linde Mark II	Union Carbide Corp.	BYJ	Class II	1981-09-23
K812522	Rabbit Complement	Dutchland Laboratories, Inc.	KTQ	Class I	1981-09-23
K812518	Ames Tda Theophylline Test	Miles Laboratories, Inc.	LER	Class II	1981-09-23
K812504	Accra Lab Wright Stain	Accra Laboratories, Inc.	IAF	Class I	1981-09-23
K812500	Ultrachem Uric Acid Aldh, Item #65047	Harleco	CDO	Class I	1981-09-23
K812497	Immulik Stain Plate	Immulok, Inc.	IEG	Class I	1981-09-23
K812496	Immunogl. Frct. of Rabbit Antiser.-Album	Dako Corp.	DCF	Class II	1981-09-23
K812495	Immunogl. Frct. of Rabbit Antiser.-Alpha	Dako Corp.	DEW	Class II	1981-09-23
K812494	Immunogl. Frct. of Rabbit Antiser.-Hapto	Dako Corp.	DAD	Class II	1981-09-23
K812493	Immunogl. Frct. of Rabbit Antiser.-Macro	Dako Corp.	DEB	Class II	1981-09-23
K812492	Immunogl. Frct. of Rabbit Antiser.-Tran	Dako Corp.	DDG	Class II	1981-09-23
K812491	Immunogl. Frct. of Rabbit Antiser.-C3	Dako Corp.	CZW	Class II	1981-09-23
K812490	Immunogl. Frct. of Rabbit Antiser.-C4	Dako Corp.	DBI	Class II	1981-09-23
K812489	Immunogl. Frct. of Rabbit Antiser.-Igg	Dako Corp.	DEW	Class II	1981-09-23
K812488	Immunogl. Frct. of Rabbit Antiser.-Iga	Dako Corp.	CZP	Class II	1981-09-23
K812487	Immunogl. Frct. of Rabbit Antiser.-Igm	Dako Corp.	DAO	Class II	1981-09-23
K812486	Immunogl. Frct. of Rabbit Antiser.-Cerul	Dako Corp.	DDB	Class II	1981-09-23
K812458	Padac	Calbiochem-Behring Corp.	JTO	Class I	1981-09-23
K812454	Pac-Aid	Albert J. Anthony, Dmd	DZC	Class I	1981-09-23
K812453	Scrippsystem Immunoglobin Rid Kit	Scripps-Miles, Inc.	DEW	Class II	1981-09-23
K812451	Campy Thioglycollate (Tube)	Granite Diagnostics, Inc.	JSD	Class I	1981-09-23
K812434	Diagnostic Kits & Kit Components	Diagnostica, Inc.	LHT	Class I	1981-09-23
K812431	Factor VIII Deficient Plasma #B8d	Sigma Chemical Co.	GGP	Class II	1981-09-23
K812429	Dale Combo Tracheostomy Tube Holder	Dale Medical Products, Inc.	EQH	Class I	1981-09-23
K812427	Cartmill/barry Feeding Tube	Impra, Inc.	KNT	Class II	1981-09-23
K812425	Beckman R.pr Control Serum Set	Beckman Instruments, Inc.	GMP	Class II	1981-09-23
K812340	Titertek Microplate Incubator	Flow Laboratories, Inc.	JTQ	Class I	1981-09-23
K812338	Preza-Pak II, Arterial Blood Sampling Sy	Terumo Medical Corp.	CBT	Class I	1981-09-23
K812249	Skin Adhesive-50Xx	Manfred Sauer Corp.	KNX	Class II	1981-09-23
K812222	Em-X	Biological Corp. of America	KSG	Class II	1981-09-23
K812123	Cytomegelisa Test Kit	M.A. Bioproducts			1981-09-23
K811464	Model 535-01 Trace-a-Pace Ekg/telemetry	Intermedics, Inc.	DXH	Class II	1981-09-23
K810897	Alpha Plastic Plasma Bottle	Alpha Therapeutic Corp.	KSR	Class II	1981-09-23
K810500	Blood Freezing Bag	Delmed, Inc.	KSR	Class II	1981-09-23
K801339	Telemetry Decoder	Intermedics, Inc.	DXY	Class III	1981-09-23
K801337	Cyberlith IX Implantable Pulse Generator	Intermedics, Inc.	DXY	Class III	1981-09-23
K812544	Reliance Ophthalmic Instrument Control	F. & F. Koenigkramer	HMF	Class I	1981-09-21
K812534	Improved Playtex Tampon	Playtex, Inc.	HIL	Class II	1981-09-21
K812513	Mini O2	Mountain Medical Equipment, Inc.	CAW	Class II	1981-09-21