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 2026-10-08, 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 3376 of 3526

510(k) clearances, page 3376 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K792336	Helena Factor II Deficient Sub. Plasma	Helena Laboratories, Corp.	GGP	Class II	1979-12-27
K792272	Dexide Dis. Sur. Scrub Sponge W/parachlo	Dexide, Inc.	GEC	Class I	1979-12-27
K792079	Model 447 Electrocardiocorder	Del Mar Avionics	DSH	Class II	1979-12-27
K792078	Model 449 Electrocardiocorder	Del Mar Avionics	DSH	Class II	1979-12-27
K792076	Model 448 Pacercorder	Del Mar Avionics	DSH	Class II	1979-12-27
K792074	Model 674 Pacer Analyzer	Del Mar Avionics	DTC	Class II	1979-12-27
K792566	The Araluen Carrier	Araluen, Inc.	FPP	Class I	1979-12-20
K792560	Master i.v. Dial Lock	The Master Medical Corp.	FPA	Class II	1979-12-20
K792538	Continu-Flo Admin. Set Code 2C/200	Travenol Laboratories, S.A.	FPA	Class II	1979-12-20
K792519	Implantable Programmable Unipolar	Telectronics, Inc.	DXY	Class III	1979-12-20
K792512	Polaroid Land Camera for Endoscopy	Polaroid Corp.	FEM	Class I	1979-12-20
K792510	Microbar Monitoring Line Filter	Medex, Inc.	FPB	Class II	1979-12-20
K792494	Catheterization Forcep	C. Intl.	GEN	Class I	1979-12-20
K792473	Therapette, Model No Mh-100	Technical Resources, Inc.	GZJ	Class II	1979-12-20
K792471	Stanford Sterile Lap Sponges	Lukens Corp.	GDY	Class I	1979-12-20
K792433	Temporary Burn Sheet with Perforated	American Medical Disposable, Inc.	FPY	Class I	1979-12-20
K792432	Temporary Burn Sheet with Perforated	American Medical Disposable, Inc.	FPY	Class I	1979-12-20
K792394	Sircam 106	Siemens Corp.	IZJ	Class II	1979-12-20
K792393	Gigantos 1012 Mp	Siemens Corp.	IZO	Class I	1979-12-20
K792392	Polyphos	Siemens Corp.	IZO	Class I	1979-12-20
K792388	Octoson	Ausonics Pty, Ltd.	IYO	Class II	1979-12-20
K792382	Stomahesive Powder	E. R. Squibb & Sons, Inc.	EXB	Class I	1979-12-20
K792345	Retrievable Forceps	Mill-Rose Laboratory	OCZ	Class II	1979-12-20
K792344	Stone and Retrieval Basket	Mill-Rose Laboratory	FFL	Class II	1979-12-20
K792331	Tommy Toes	Tommy Toes	FQM	Class I	1979-12-20
K792327	Integron	Tecnomed, Inc.	IZF	Class II	1979-12-20
K792318	Skil-Care Turn and Hold Pad	Skil-Care Corp.	FMR	Class I	1979-12-20
K792305	A Sleep Assessment Device	Farrall Instruments, Inc.	LEL	Class II	1979-12-20
K792298	The Versa-Bed	First & Ten, Inc.	FNJ	Class I	1979-12-20
K792297	Span Aids Kit	American Hospital Supply	FMP	Class I	1979-12-20
K792295	Sorbies	American Hospital Supply	FRL	Class I	1979-12-20
K792227	Multi-Ad Fluid Dispensing System	National Patent Development Corp.	KYX	Class I	1979-12-20
K792225	P1806 Mobile C-Arm Image Intensifier	Precise Optics	JAA	Class II	1979-12-20
K791895	Accessories for Sys. 400 CO2 Surg. Laser	Coherent Medical Division	GEX	Class II	1979-12-20
K792580	Pacemaker Programmer	Cardiac Pacemakers, Inc.	KRG	Class III	1979-12-19
K792576	Castroviejo Vascular Scissors	Edward Weck, Inc.	DWS	Class I	1979-12-19
K792572	Empire Spirometer	Empire Plastics Manufacturer	BZK	Class II	1979-12-19
K792571	Counter Unit	Empire Plastics Manufacturer	BWF	Class II	1979-12-19
K792564	Ma-1 Ventilator & Timeter Aircompressor	Eastern Anesthesia, Inc.	CBK	Class II	1979-12-19
K792561	Mini-H-Fixation	Geny Medical, Inc.	JEC	Class II	1979-12-19
K792499	Ambu Paedi Anaesthesia System	Narco Air-Shields	CAI	Class I	1979-12-19
K792461	Centrix Mkiv Endodontic Delivery	Centrix, Inc.	EIC	Class I	1979-12-19
K792450	Arterial Blood Filter, Model Af-10	Bentley Laboratories, Inc.	DTM	Class II	1979-12-19
K792372	Ipos Breast Prosthesis	Ipos KG	GBI	Class I	1979-12-19
K792288	Tryptone Broth (Tryptophane Broth)	Isle Media and Sterile Products, Inc.	JSH	Class I	1979-12-19
K792287	Kf Streptococcus Agar	Isle Media and Sterile Products, Inc.	JSJ	Class I	1979-12-19
K792286	Mr-Vp Medium	Isle Media and Sterile Products, Inc.	JSH	Class I	1979-12-19
K792284	Culturia Emb/columbia Cna W/5% Sheep	Clinical Convenience Products, Inc.	JXA	Class I	1979-12-19
K792276	Brain Heart Infusion W/paba, O.1%,	BD Becton Dickinson Vacutainer Systems Preanalytic	JSG	Class I	1979-12-19
K792267	Pentex Bronchofiberscope Model Fb-17A	Pentax Precision Instrument Corp.	EOQ	Class II	1979-12-19