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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2959 of 3529

510(k) clearances, page 2959 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K853222	Slimline Unipolar Endocardial Pacing Lead, #30-402	Telectronics, Inc.	DTB	Class III	1985-09-17
K853221	Slimline Unipolar Endocardial Pacing Lead,#30-401	Telectronics, Inc.	DTB	Class III	1985-09-17
K852709	Implant Elect Lead, Mod 30-403 Using Polyu 90 a	Telectronics, Inc.	DTB	Class III	1985-09-17
K852512	Thrombo Screeen Fibrin Degradation Product Kit	Pacific Hemostasis	GHH	Class II	1985-09-17
K852472	Abbott Rsv Eia	Abbott Medical	LKT	Class I	1985-09-17
K852446	Endocardial Screw-in Lead with Platinum Porous Tip	Diag Corp.	DTB	Class III	1985-09-17
K852371	Cell-Dyn 2000 Automated Multi-Parameter Hematology	Abbott Diagnostics	GKZ	Class II	1985-09-17
K852294	Bard-Parker Occlusion Balloon Catheter	BD Becton Dickinson Vacutainer Systems Preanalytic	DYG	Class II	1985-09-17
K851220	Sunbeam Evaporative Humidifier 663 & 664	Northern Electric Co. Div. of Sunbeam Corp.	KFZ	Class I	1985-09-17
K851036	Sonolayer-V, Ssa-90A	Toshiba Medical Systems	ITX	Class II	1985-09-17
K850677	Teleflex Guidewire	Teleflexmedical, Inc.	DQX	Class II	1985-09-17
K844445	Revive System	Revive Systems Corp.	LKY	Class II	1985-09-17
K853772	Precept Methicillin	Austin Biological Laboratories	LTW	Class II	1985-09-16
K853685	Precept Tm Carbenicillin	Austin Biological Laboratories	LTW	Class II	1985-09-16
K853677	Tdx Rea Bun	Abbott Medical	CDQ	Class II	1985-09-16
K853656	Qca Enzymatic Glucose	BD Becton Dickinson Vacutainer Systems Preanalytic	CGA	Class II	1985-09-16
K853634	Corning Cell Wells-Multiple Well Plates	Corning Medical & Scientific	KIZ	Class I	1985-09-16
K853619	Apl Triple Sugar Iron Agar	Apl Medical Supplies	JSH	Class I	1985-09-16
K853618	Apl Sim Medium	Apl Medical Supplies	JSH	Class I	1985-09-16
K853617	Apl Simmons Citrate Agar	Apl Medical Supplies	JSI	Class I	1985-09-16
K853610	Apl Motility Indole Ornithine Agar	Apl Medical Supplies	JSH	Class I	1985-09-16
K853601	Morgan Arthroscopic Menesus & Synovial Rasp	Bowen & Company, Inc.	GAC	Class I	1985-09-16
K853596	Precept Cefoperazone	Austin Biological Laboratories	LTW	Class II	1985-09-16
K853592	Magnesium	Horiba Instruments Incorporated	JGJ	Class I	1985-09-16
K853583	Modern Medical Products Towel Clamp	Modern Medical Products	GDJ	Class I	1985-09-16
K853553	Diascan Control	Home Diagnostics, Inc.	JJX	Class I	1985-09-16
K853547	Stratus N-Acetylprocainamide Fluorometric Enzyme I	American Dade	LAN	Class II	1985-09-16
K853533	Absorbance Test Solution	Diagnostic Systems	JIT	Class II	1985-09-16
K853532	Alcohol Calibrators	Diagnostic Systems	DNN	Class II	1985-09-16
K853469	Gilford Immunoglobulin M Reagent	Gilford	DFT	Class II	1985-09-16
K853468	Gilford C4 Complement Reagent	Gilford	DBI	Class II	1985-09-16
K853467	Gilford Immunoglobulin a Reagent	Gilford	CZP	Class II	1985-09-16
K853466	Gilford C3 Complement Reagent	Gilford	CZW	Class II	1985-09-16
K853465	Gilford Immunoglobulin G Reagent	Gilford	DEW	Class II	1985-09-16
K853273	Precept Ceftriaxone	Austin Biological Laboratories	LTW	Class II	1985-09-16
K853215	Accu-Flo Pressure Valve	Cerenovus, Inc.	JXG	Class II	1985-09-16
K853205	Proximal Porocoat Modified Medical Aspect Aml Hip	Depuy, Inc.			1985-09-16
K853127	Micromedic Combostat B B12/folate(boil)	Micromedic Systems	CDD	Class II	1985-09-16
K852972	Implantable Electrode Lead, Model 030-400	Telectronics, Inc.	DTB	Class III	1985-09-16
K852808	Cr26, Cr26a, Cr26b, Cr26c(cardiac Dc Defibrillato)	Cardiac Recorders, Ltd.	LDD	Class II	1985-09-16
K852799	2006, 2010, 2011, 2012(Cardiac Dc Defibrillator)	Cardiac Recorders, Ltd.	LDD	Class II	1985-09-16
K852797	Heparin Coat Tran Ballo Tip Temp Pac Electrode	Mansfield Scientific, Inc.	LDF	Class II	1985-09-16
K852779	Microtrak Chlamydia Trachomatis Dir Specimen Test	Syva Co.	LJP	Class I	1985-09-16
K852513	115-Gk Bard Care Translu Ventricular Pacing Lead	C.R. Bard Inc	LDF	Class II	1985-09-16
K852494	Cmv-Iha	Hillcrest Biologicals	LJO	Class II	1985-09-16
K852478	Enzygnost + Anti-Cmv Igg Test	Behring Diagnostics, Inc.	LFZ	Class II	1985-09-16
K852469	Saf-D-Fib	Medtronic Andover Medical, Inc.	DRX	Class II	1985-09-16
K852455	Gambro Digital Telethermometer Tth 10-200	Gambro, Inc.	KRI	Class I	1985-09-16
K852335	Sterilization Container	Bemis Mfg. Co.	FRG	Class II	1985-09-16
K852133	Reflotron System	Boehringer Mannheim Corp.	JJE	Class I	1985-09-16