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 3380 of 3526

510(k) clearances, page 3380 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K792364	Tee Adapter	Airlife, Inc.	CAF	Class II	1979-12-04
K792356	Oxequip Model 34 Med*star Oxygen Monitor	Oxequip Health Ind.	CCL	Class II	1979-12-04
K792335	Helena Factor VIII Deficient Sub. Plasma	Helena Laboratories, Corp.	GGP	Class II	1979-12-04
K792310	Norm-Trol	Helena Laboratories, Corp.	JPA	Class II	1979-12-04
K792306	Rh Viewbox	Tekpro	KSY	Class I	1979-12-04
K792257	Temperature Monitor (W/probe)	Biotronex Laboratory, Inc.	FLL	Class II	1979-12-04
K792209	Sandare Hemoglobin Controls	Sandare Chemical Co., Inc.	JPK	Class II	1979-12-04
K792134	Bonchek-Shiley Vein Distention System	Shiley, Inc.	DWP	Class II	1979-12-04
K792114	Emit-Barbiturate Assay	Syva Co.	DIS	Class II	1979-12-04
K792112	Conphar Stethscope	Conphar, Inc.	DQD	Class II	1979-12-04
K792108	Conphar Blood Pressure Cuffs	Conphar, Inc.	DXQ	Class II	1979-12-04
K792080	Model 656 Arrhythmia Analyzer	Del Mar Avionics	DXG	Class II	1979-12-04
K792077	Model 1981 Pressurometer Data Analysis	Del Mar Avionics	DSK	Class II	1979-12-04
K792075	Model 1978 Pressurometer III Ambulatory	Del Mar Avionics	DXN	Class II	1979-12-04
K792071	Dcg Data Terminal	Del Mar Avionics			1979-12-04
K792060	Temptronic 100 Water Bath	Sybron Corp.	JTQ	Class I	1979-12-04
K792015	P-2 Ultrasonic Arteriograph	D. E. Hokanson, Inc.	DPT	Class II	1979-12-04
K791497	Prostatic Acid Radioimmunoassay Test	Clinical Assays, Inc.	JFH	Class II	1979-12-04
K792309	Castroviejo Vascular Needleholder 538425	Edward Weck, Inc.	GEN	Class I	1979-11-30
K792278	Dahlberg Model Ae High Frequency / Aid	Dahlberg Electronics, Inc.	ESD	Class I	1979-11-30
K792274	Tempo	Deringer-Ney, Inc.	EJS	Class II	1979-11-30
K792248	Taylor Traction Cord	Taylor Medical Equipment	HST	Class I	1979-11-30
K792247	Taylor Patient Transfer Board	Taylor Medical Equipment	IKX	Class I	1979-11-30
K792241	Pelimit	Colmed, Ltd.	IRN	Class II	1979-11-30
K792238	Crptell	Central Biological Co.	DCK	Class II	1979-11-30
K792223	Pacesetter Model 350	Cynergy	DTE	Class II	1979-11-30
K792201	Strep Culturette	Marion Health & Safety, Inc.	JSN	Class I	1979-11-30
K792184	Lab-Tek Ana Test Kit	Miles Laboratories, Inc.	DHN	Class II	1979-11-30
K792146	Atomic Spectroscopy System	Revvity Health Sciences, Inc.	JXR	Class I	1979-11-30
K792140	Composite Restorative, Paste/type	Scientific Pharmaceuticals, Inc.	EBF	Class II	1979-11-30
K792086	Glyco-Spin	Applied Clinical Research Laboratories	LCP	Class II	1979-11-30
K792042	Denture Base Resin	Dentsply Intl.	EBI	Class II	1979-11-30
K792032	Leif Centrifugal Cytology Bucket	Robert C. Leif, Ph.D.	IFB	Class I	1979-11-30
K792299	Arcolith 3020-Cardiac Pulse Generator	Arco Medical Products Co.	DXY	Class III	1979-11-29
K792216	Arcolith 2100-Cardiac Pulse Generator	Arco Medical Products Co.	DXY	Class III	1979-11-29
K792142	Model IV 6500 Formulator	Medtronic, Inc.	FRN	Class II	1979-11-29
K791920	Cardiac Pacemaker P4000 Ser. & P1000	Vitatron Medical BV	DXY	Class III	1979-11-29
K792315	A.d.e. Aspen Dispersive Electrode	Zimmer GmbH	GEI	Class II	1979-11-27
K792304	Mw-8000	Midwest	EFB	Class I	1979-11-27
K792303	Mw 8000-I	Midwest	EBF	Class II	1979-11-27
K792302	Ls-100	Midwest	EFB	Class I	1979-11-27
K792281	Usher's Marlex Tubular Mesh	Davol, Inc.	FTL	Class II	1979-11-27
K792268	Circapak	Respiratory Care, Inc.	BZO	Class I	1979-11-27
K792265	Shiley Pressure Relief Adapter Pra	Shiley, Inc.	BSK	Class II	1979-11-27
K792234	Single Vial Colorimetric/triglycerides	Boehringer Mannheim Corp.	CDT	Class I	1979-11-27
K792232	Unifocal 3-2 Models Unipolar & Bipolar	American Pacemaker Corp.	DXY	Class III	1979-11-27
K792218	Misty Bebulizer	Airlife, Inc.	CAF	Class II	1979-11-27
K792217	Air Incentive Spirometer, W/nebulizer	Airlife, Inc.	BWF	Class II	1979-11-27
K792214	Model Tm2-Behind-the-Ear Tinnitus	Starkey Laboratories, Inc.	BWF	Class II	1979-11-27
K792208	Durazyme Got/ast	American Monitor Corp.	CIT	Class II	1979-11-27