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 1867 of 3531

510(k) clearances, page 1867 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K972569	E-Type Speed Increaser Contra Angle, External Irrigation, Internal Irrigation	Nsk Nakanishi, Inc.	EGS	Class I	1997-10-08
K972204	Acu-Ray HF Series Portable X-Ray Unit	Sterne Equipment Co., Ltd.	IZL	Class II	1997-10-08
K971877	Lilliput 2 Infant Hollow Fiber Oxygenator	Dideco S.p.A.	DTZ	Class II	1997-10-08
K971712	Coeur 130 Ml Angiographic Syringe	Coeur Laboratories, Inc.	DXT	Class II	1997-10-08
K971273	Index 2E, Index 2F, Index 2Ef, Cardiosat 100E, Cardiosat 100F, Cardiosat 100Ef	Bio-Tek Instruments, Inc.	DQA	Class II	1997-10-08
K970233	Gelbfish Endo-Vac System	Gary A. Gelbfish	MCW	Class II	1997-10-08
K963914	Cm & Cm Ds-7	Konica Medical Corp.	IXA	Class II	1997-10-08
K963913	Md100 & Mm150	Konica Medical Corp.	EAM	Class I	1997-10-08
K973629	Precinorm RF, Precipath RF	Boehringer Mannheim Corp.	JJY	Class I	1997-10-07
K973245	Tokuso Rebase Mr. Bond	Tokuyama America Inc.	KLE	Class II	1997-10-07
K973086	Pla-96P	Southern Dental Industries, Inc.	EJJ	Class II	1997-10-07
K972847	Kodak Digital Science 9000D Medical Laser Printer (9000D)	Eastman Kodak Company	LMC	Class II	1997-10-07
K972825	Opta5 Pta Balloon Catheter, Powerflex Pta Balloon Catheter, Ultra-Thin Diamond Balloon Catheter, Palmaz Balloon Expandab	Cordis US Corp.	FGE	Class II	1997-10-07
K972678	Millennium Crt Infusion Pump and Millennium Crt Infusion Pump Administration Sets	Mcgaw, Inc.	FRN	Class II	1997-10-07
K972558	Bipolar Scissors	Enable Medical Corp.	GEI	Class II	1997-10-07
K971643	Rusch Brillant Balloon Catheter	Rusch Intl.	EZL	Class II	1997-10-07
K971590	Tactylon Condom	Sensicon Corp.	MOL	Class II	1997-10-07
K973487	Cefpodoxime Antimicrobial Susceptibility Test Disc	Oxoid, Ltd.	JTN	Class II	1997-10-06
K973367	Abl555 Blood Gas, Electrolyte & Metabolite System	Radiometer America, Inc	CHL	Class II	1997-10-06
K973358	Myoglobin Control Set	Boehringer Mannheim Corp.	JJX	Class I	1997-10-06
K973126	Triage Cardiac Panel, Triage Troponin-I, Triage Ck-Mb, Triage Myoglobin, Triage Troponin-I and Ck-Mb, Triage Troponin-I	Biosite Incorporated	JHX	Class II	1997-10-06
K973074	2487 Dual Wavelength Absorbance Detector	Waters Corporation	KZR	Class I	1997-10-06
K972974	Accuwell T4-Eia	Neometrics, Inc.	KLI	Class II	1997-10-06
K972811	Howmedica Fully Threaded Screws	Howmedica Corp.	HSB	Class II	1997-10-06
K972561	Nuvolase 660 Laser System for Ophthalmology	American Laser Medical	GEX	Class II	1997-10-06
K972342	Reaads Protein C Antigen Test Kit	Reaads Medical Products, Inc.	GGP	Class II	1997-10-06
K973392	Chemmate Lambda	Ventana Medical Systems Inc	DEM	Class II	1997-10-03
K973391	Chemmate Kappa	Ventana Medical Systems Inc	DEM	Class II	1997-10-03
K973390	Chemmate L26 (Cd20)	Ventana Medical Systems Inc	DEM	Class II	1997-10-03
K973389	Chemmate Uchl1 (Cd45ro) Prediluted Antibody for Immunohistochemical Staining	Ventana Medical Systems Inc	DEM	Class II	1997-10-03
K973294	Innovatome Microkeratome	Innovative Optics, Inc.	HNO	Class I	1997-10-03
K973088	Pls-96P	Southern Dental Industries, Inc.	EJJ	Class II	1997-10-03
K972895	Vidas Rotavirus (Rtv) Assay	Biomerieux Vitek, Inc.	LIQ	Class I	1997-10-03
K972844	Temp Bond Clear	Kerr Dental Materials Center	EMA	Class II	1997-10-03
K972697	Aia-Pack Ige II Assay	Tosoh Medics, Inc.	DGC	Class II	1997-10-03
K972661	Eye Sphere, Conformers	Gulden Ophthalmics	HPZ	Class II	1997-10-03
K972514	Laserex Lp1532 Photocoagulator	Ellex Medical Pty Ltd	HQF	Class II	1997-10-03
K972169	Medi-Plus, Health-Plus, Sanitex, Reliance	Pwa Industries Sdn. Bhd.	LZA	Class I	1997-10-03
K971947	Innosan Travelair S Plus Portable Oxygen Concentrator, Code No. M407001853 (with Ac Power Supply Accessory)	Sim Italia S.r.l.	CAW	Class II	1997-10-03
K971257	Vtu-1 Vacuum Erection System	Mckenna & Cuneo	LKY	Class II	1997-10-03
K971198	Babytherm 8004 Babytherm 8010	Drager, Inc.	FMT	Class II	1997-10-03
K971131	Fukuda Denshi Model Ds-5100E Portable Patient Monitor	Fukuda Denshi USA, Inc.	DSI	Class II	1997-10-03
K971056	Magellan Magnetic Distal Targeting System(proposed Name), Product Line Extension	Wrightmedicaltechnologyinc	HSB	Class II	1997-10-03
K970570	Nivp3 (Windows Version of Nivp	D. E. Hokanson, Inc.	DQK	Class II	1997-10-03
K970456	Hewlett Apckard Series 50 Ob Tracevue Obstetrical Surveillance and Archiving System	Hewlett-Packard Co.	HGM	Class II	1997-10-03
K965226	Expert-Xl Total Body Acquisition and Analysis Software	Lunar Corp.	KPS	Class II	1997-10-03
K964617	Ge Logiq 700 Diagnostic Ultrasound System	GE Healthcare	IYO	Class II	1997-10-03
K973107	Amsino i.v. Administration Set	Amsino Intl., Inc.	FPA	Class II	1997-10-02
K973047	One Step Urine Drug of Abuse Barbiturate Test	Drial Consultants, Inc.	DIS	Class II	1997-10-02
K972892	Cavit-Lc	Espe GmbH & Co. KG.	EBF	Class II	1997-10-02