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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 1885 of 3531

510(k) clearances, page 1885 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K972094	Target Cardiac Troponin I Test	Texas Immunology, Inc.	MMI	Class II	1997-07-23
K971968	Safe Connect Surgical Cable (S-101-97/S-201-97/Fl-601-97)	Remington Medical	DSA	Class II	1997-07-23
K971943	Myringotomy Tube	Mednet Locator, Inc.	ETD	Class II	1997-07-23
K971942	Sled, Finger, Handle	Esaote North America, Inc	ITX	Class II	1997-07-23
K971843	Laserscope Vela Erbium:yag Laser System and Accessories	Laserscope	GEX	Class II	1997-07-23
K971784	Zeus Scientific, Inc., Anticardiolipin Igg/igm Elisa Test System	Zeus Scientific LLC	MID	Class II	1997-07-23
K971718	Micro-Seal Acetabular System	Whiteside Biomechanics, Inc.	LPH	Class II	1997-07-23
K971669	Cobe Hvr 4000 Filtered and Nonfiltered Hardshell Venous Reservoir	LivaNova USA, Inc.	DTN	Class II	1997-07-23
K971667	Cardiac Phased Array Coil	GE Healthcare	MOS	Class II	1997-07-23
K971648	Sharplan Erbium: Yag Laser (4020)	Sharplan Lasers, Inc.	GEX	Class II	1997-07-23
K971532	Arthrocare Electrosurgery System	ArthroCare Corporation	GEI	Class II	1997-07-23
K971516	Cordis Powerflex Plus Pta Balloon Catheter	Cordis US Corp.	LIT	Class II	1997-07-23
K971388	Freerider, Model Fr168-4	Freerider USA, Inc.	INI	Class II	1997-07-23
K971387	Freerider, Model Fr510-F	Freerider USA, Inc.	INI	Class II	1997-07-23
K971298	Better Hearing, Inc. Model L-1 Hearing Aid	Better Hearing, Inc.	ESD	Class I	1997-07-23
K971165	Introducer Sheath and Dilator	Boston Scientific Corporation	LDF	Class II	1997-07-23
K965247	Envoy Guiding Catheter	Cordis Neurovascular, Inc.	DQY	Class II	1997-07-23
K965198	Ultima Tps Cemented Stem	Johnson & Johnson International	KWL	Class II	1997-07-23
K965010	Target 2 Version 1.1	GE Healthcare	IYE	Class II	1997-07-23
K964408	Poseidon Cardiac Monitoring System (Pcms)	Instromedix, Inc.	DPS	Class II	1997-07-23
K963987	Camouflage Cuff Savers	N.A. Braggs Medical, Inc.	DXQ	Class II	1997-07-23
K962060	Strep a Oia Max	Biostar, Inc.	GTZ	Class I	1997-07-23
K961817	B Smart Model 1	Koven Technology, Inc.	LEL	Class II	1997-07-23
K972404	Vacutainer Brand Safety Blood Collection Assembly(multiple)	BD Becton Dickinson Vacutainer Systems Preanalytic	KJA	Class I	1997-07-22
K972041	Ez Hdl Cholesterol Reagent(procedure 354)/Ez Hdl Calibrator (354-5)	Sigma Diagnostics, Inc.	LBS	Class I	1997-07-22
K972011	Opus Ethanol	Behring Diagnostics, Inc.	DIC	Class II	1997-07-22
K971801	Laparotomy Bladder Neck Suspension Kit	Louisville Laboratories, Inc.	EZL	Class II	1997-07-22
K971797	Laparoscopic Bladder Neck Suspension Kit	Louisville Laboratories, Inc.	HET	Class II	1997-07-22
K971761	Personallab Automated Microplate Analyzer	Biochem Immunosystems (U.S.), Inc.	JJE	Class I	1997-07-22
K971754	Liquid Glucose (Hexokinase) Reagent Set	Horiba Instruments Incorporated	CFR	Class II	1997-07-22
K971620	Quanta Lite Rubeola (Measles) Igg	Inova Diagnostics, Inc.	LJB	Class I	1997-07-22
K971437	Bionicare Stimulator System. Model Bio-1000	Murray Electronics	NYN	Class II	1997-07-22
K971223	Cryo Check Factor V Deficient Plasma	Precision Biologicals, Inc.	GJT	Class II	1997-07-22
K971182	Tox A/b Test	Techlab, Inc.	LLH	Class I	1997-07-22
K963898	Model 6495 Bipolar Temporary Pacing Lead	Medtronic, Inc.	LDF	Class II	1997-07-22
K962950	Cadplan, Version 2.62. Radiation Therapy Treatment Planning System	Varian Medical Systems, Inc.	IYE	Class II	1997-07-22
K972416	Momo Design or Momo	Momo U.S.A., Inc.	HQY	Class I	1997-07-21
K971758	Cauterization Smoke Evacuator	Applied Medical Technologies	GEI	Class II	1997-07-21
K971706	Tiadapt Abutment System	Nobel Biocare Uas, Inc.	NHA	Class II	1997-07-21
K971641	Antibacterial Gutta Percha	Dr. Howard Martin, P.A.	EKM	Class I	1997-07-21
K971608	Cordis Brite Tip Catheter Sheath Introducer System	Cordis US Corp.	DYB	Class II	1997-07-21
K971138	Dinabase (Tm)	Sultan Chemists, Inc.	EBI	Class II	1997-07-21
K971019	Chase Vessel Cannula	Chase Medical, Inc.	DWF	Class II	1997-07-21
K970573	Flexart V3.5 Software	Toshiba America Mri, Inc.	LNH	Class II	1997-07-21
K970178	Clog Zapper Enteral Feeding Tube Declogging System	Corpak Co.	KNT	Class II	1997-07-21
K964952	Veridose V (Five), Model Number 37-705	Victoreen, Inc.	JAD	Class II	1997-07-21
K963790	Uni-Graft K Dv	Atrium Medical Corporation	DSY	Class II	1997-07-21
K960587	Cprotector 2000	Certified Safety Mfg Inc	CBP	Class II	1997-07-21
K972671	Bun (Liquid) Reagent Set	Horiba Instruments Incorporated	CDQ	Class II	1997-07-20
K972131	Breath Ace Breathfreshener	Beyond 21st Century, Inc.	LCN	Class I	1997-07-18