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 3441 of 3526

510(k) clearances, page 3441 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K781192	Knife, Rocker, Slotted Handle	Fred Sammons, Inc.	ILC	Class I	1978-07-31
K781191	Sporks, Plastic, Disp.	Fred Sammons, Inc.	ILC	Class I	1978-07-31
K780879	Urethro Catheterization Tray	Abco Dealers, Inc.	FCM	Class II	1978-07-31
K780878	Leg Bag	Abco Dealers, Inc.	KNX	Class II	1978-07-31
K780849	Dentrol Liquid Denture Adhesive	Block Drug Company, Inc.			1978-07-31
K780310	Dermatron Iontophoresis Device	Motion Control, Inc.			1978-07-31
K781013	Enzymatic Reagent for Cholesterol Meas	Coulter Electronics, Inc.	CHH	Class I	1978-07-28
K780809	Generator, Pulse Models 5920/5921	Medtronic, Inc.	DXY	Class III	1978-07-28
K780741	Generator, Pulse, Demand, Model 5996	Medtronic, Inc.	DXY	Class III	1978-07-28
K780660	Nite Train'r	Nite Train-R Enterprises, Inc.	KPN	Class II	1978-07-28
K780623	Endocardial Atrial Pacing Lead, M. 6994	Medtronic, Inc.	DTB	Class III	1978-07-28
K780622	Bipolar Endocardial Pacing Lead, M. 6902	Medtronic, Inc.	DTB	Class III	1978-07-28
K781223	Oxygenator, Blood, Infant/pediatric	Shiley, Inc.	DTZ	Class II	1978-07-27
K781220	Anti-Human Lambda Serum	Icl Scientific	DEH	Class II	1978-07-27
K781218	Anemometer, Nasal, Exeter	Medika Corp.	ETL		1978-07-27
K781213	Compressor, Air, Mini-Silent	The John Bunn Co.	BTI	Class II	1978-07-27
K781179	Wrench, Gexagon, Driver	Telectronics, Inc.	DTF	Class I	1978-07-27
K781165	Cholesterol & Hdl Chol. Procedure	Data Medical Associates, Inc.			1978-07-27
K781150	Ria Tsh in Human Serum or Plasma	Diagnostic Corp. of America	JLW	Class II	1978-07-27
K781145	Monitor Kits, Blood Level	3M Health Care, Sarns	DTW	Class II	1978-07-27
K781077	Control, Hematology, Ch-60	Dade, Baxter Travenol Diagnostics, Inc.	JPK	Class II	1978-07-27
K781054	Lifeline Ambulatory	Imc	DPS	Class II	1978-07-27
K781045	A-33 Dental Alloy	Howmedica Corp.	EJT	Class II	1978-07-27
K781042	Prolith 23S Pacemaker	Edwards Pacemaker Systems	DXY	Class III	1978-07-27
K781031	Aeroplast Dressing	Parke-Davis Co.	KMF	Class I	1978-07-27
K781028	Kappa Serum (Free & Bound) Anti-Human	Icl Scientific	DFH	Class II	1978-07-27
K781027	Kappa Serum (Free) Anti-Human	Icl Scientific	DFH	Class II	1978-07-27
K781025	Lambda Serum (Free) Anti-Human	Icl Scientific	DEH	Class II	1978-07-27
K781020	(Ast) or (Alt) UV Determ. Phy. Phos.	The Dow Chemical Co.	CIT	Class II	1978-07-27
K781012	Ria Test Kit Sys. Damon Kiquisol Free	Damon Corp.	CEC	Class II	1978-07-27
K781010	Mercury/hydride Atomic Absorption Access	Revvity Health Sciences, Inc.	DPH	Class I	1978-07-27
K781009	Analyzer, Serum Iron & Total Iron Bindin	Environmental Sciences Assoc., Inc.	JMD	Class I	1978-07-27
K781004	Hma Uric Acid Test	Hycel, Inc.	KNK	Class I	1978-07-27
K780998	Scalpel	Isolab, Inc.	GDX	Class I	1978-07-27
K780997	Amalgam Alloy	Syntex Corp.	EJJ	Class II	1978-07-27
K780985	PVC Lines for Monitoring	Norton Performance Plastics Corp.	GAZ	Class II	1978-07-27
K780983	Calcium Reagent System No. 585	Sigma Chemical Co.	CIC	Class II	1978-07-27
K780980	Platelet Control	Bhp Diagnostix, Inc.	JPK	Class II	1978-07-27
K780974	Bacillus Pumilus	Urol, Inc.	FRL	Class I	1978-07-27
K780973	Signapad	Parker Laboratories, Inc.	GYB	Class II	1978-07-27
K780970	Burette Set with Air Control Lever	Travenol Laboratories, S.A.	FPA	Class II	1978-07-27
K780964	Transport Incubator	Cavitron Corp.	FPL	Class II	1978-07-27
K780962	Automated Enzyme	Hyland Therapeutic Div., Travenol Laboratories	KSK	Class II	1978-07-27
K780946	Royco Model 970 Hematology Data Analyzer	Hycel, Inc.	JPJ	Class II	1978-07-27
K780945	Liquid Chromatograph Model 860	E.I. Dupont de Nemours & Co., Inc.	KZR	Class I	1978-07-27
K780944	Liquid Chromatograph Model 850	E.I. Dupont de Nemours & Co., Inc.	KZR	Class I	1978-07-27
K780943	Bun Test Uni-UV Blood Urea Nitrogen Test	Sclavo, Inc.	CDQ	Class II	1978-07-27
K780941	Conductive Cushion	Markham Service Co., Inc.	KIC	Class I	1978-07-27
K780933	Prep I Automated Sample Processor	E.I. Dupont de Nemours & Co., Inc.	LDM	Class I	1978-07-27
K780859	Princeton Biomedix Uricase (UV)	BD Becton Dickinson Vacutainer Systems Preanalytic	CDO	Class I	1978-07-27