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 1630 of 3531

510(k) clearances, page 1630 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K010011	Te-2000 Power Tilt/power Elevating Seat Combination System	Accelerated Rehab Designs, Inc.	ITI	Class II	2001-01-12
K003970	Contour Labral Nail, Model 533520A	Bionx Implants, Inc.	MAI	Class II	2001-01-12
K003969	Elecsys Ca 125 II Calset	Roche Diagnostics GmbH	JIS	Class II	2001-01-12
K003967	Ca 125 II Calcheck	Roche Diagnostics GmbH	JJX	Class I	2001-01-12
K003874	Cbc-4K Hematology Control	R & D Systems, Inc.	JPK	Class II	2001-01-12
K003862	Mada Wheelchairs	Mada Medical Products, Inc.	IOR	Class I	2001-01-12
K003783	Medical Depot-Wheelchairs, Model Sentra,astaire and Viper	Medical Depot Inc.	IOR	Class I	2001-01-12
K003775	Portable Breast Compression Device	Pem Technologies	IYX	Class I	2001-01-12
K003686	Hardydisk Ticarcillin/clavulanic Acid, 85Mcg	Hardy Diagnostics	JTN	Class II	2001-01-12
K003537	Hardydisk Rifampin, 5Mcg	Hardy Diagnostics	JTN	Class II	2001-01-12
K003536	Hardydisk Nafcillin, 1 Mcg	Hardy Diagnostics	JTN	Class II	2001-01-12
K003476	Mps Acacia Pain Kit	Mps Acacia	MEB	Class II	2001-01-12
K003406	Guarded Needle 2000	International Medical Device Partners, Inc.	FMI	Class II	2001-01-12
K003348	E.n.s.i. Retractable Safety Syringe	Ensi-Med International Pty., Ltd.	MEG	Class II	2001-01-12
K003258	Ms-One, Model Ms-1	Home Wellness West	GZJ	Class II	2001-01-12
K003253	Biomet's Minimally Constrained Elbow	Zimmer GmbH	JDC	Class II	2001-01-12
K003231	Hms Neuromuscular Stimulator, Model Hms 3	Home Medical Services	GZJ	Class II	2001-01-12
K003226	The Lifecore Stage-1 Single Stage Rbm Dental Implant System	Lifecore Biomedical LLC	DZE	Class II	2001-01-12
K003223	Geon Digital Clinical Thermometer	Geon Corp.	FLL	Class II	2001-01-12
K002457	!Nsure Fecal Occult Blood Test	Enterix, Inc.	KHE	Class II	2001-01-12
K002450	Genua Menopause Monitor Test Kit	Genua 1944, Inc.	CGJ	Class I	2001-01-12
K001775	Zoe Medical Nightingale Monitoring System	Zoe Medical, Inc.	DRT	Class II	2001-01-12
K001259	2-Piece Post and Core for the B.a.s.i.c. Dental Implant System	Basic Dental Implant Systems, Inc.	DZE	Class II	2001-01-12
K003972	Numed Ghost II Pta Catheters	Numed Inc	LIT	Class II	2001-01-11
K003902	Multitrack Angiographic Catheter	NuMED, Inc.	DQO	Class II	2001-01-11
K003848	Hoffmann II External Fixation System 90 Degree Post	Howmedica Osteonics Corp	JEC	Class II	2001-01-11
K003683	Avante Curelight	Jeneric/Pentron, Inc.	EBZ	Class II	2001-01-11
K003513	Taxol Administration Set	Abbott Medical	FPA	Class II	2001-01-11
K003485	Care Provider Station Addition of Weight Scale	Cybercare Technologies, Inc.	DQD	Class II	2001-01-11
K003396	Burn Jel Plus	Water-Jel Technologies, LLC	MGQ	Unclassified	2001-01-11
K003313	Filac Fas Temp Electronic Thermometer	Kendall	FLL	Class II	2001-01-11
K003273	Lactosorb Screw Anchor	Zimmer GmbH	MAI	Class II	2001-01-11
K002381	Pentaferte Single Use Syringes, Model Size=various Sizes	Pentaferte S.P.A	FMF	Class II	2001-01-11
K002163	Microstream External Battery Charger	Oridion Medical 1987 Ltd.	CCK	Class II	2001-01-11
K002067	Radianalyzer, Model 12710	Radi Medical Systems AB	DSK	Class II	2001-01-11
K002056	Micrus Microcoil Delivery System, Mds03	Micrus Corp.	HCG	Class II	2001-01-11
K001859	Penile Constrictor Ring	Basic Solutions, LLC	LKY	Class II	2001-01-11
K001577	Outback Catheter	Lumend, Inc.	DQY	Class II	2001-01-11
K001174	Cosmed Quark	Cosmed S.r.l.	BZC	Class II	2001-01-11
K003603	Bio Herador Sg, Bio Header Gg, Herador S, Bio Herador N, Herabond, Heraloy G, Albabond, Bio Maingold Sg, Maingold Sg, He	Jelenko Co.	EJT	Class II	2001-01-10
K003237	U2 Hip Stem, Ti Porous Coated	United Orthopedic Corp.	LPH	Class II	2001-01-10
K003202	Family of Altus Medical Coolglide Aesthetic Lasers, Models I & II	Altus Medical, Inc.	GEX	Class II	2001-01-10
K003199	Triad II Modular Total Hip System	Osteoimplant Technology, Inc.	LPH	Class II	2001-01-10
K003675	Shanghai China Star Corp Powdered Blue Nitrile Patient Examination Gloves	Shanghai China Star Corp	LZA	Class I	2001-01-09
K003619	Dried Gram-Positive Mic/combo Panels	Dade Microscan, Inc.	LTT	Class II	2001-01-09
K003518	Rapidd Highspeed Dental Handpiece	Dentsply Intl.	EFB	Class I	2001-01-09
K003457	Unigraft	Unicare Biomedical, Inc.	LYC	Class II	2001-01-09
K003387	Aurofilm Np	Metalor Dental USA Corp.	EJH	Class II	2001-01-09
K003186	Bard Memotherm Endoscopic Biliary Stent	C.R. Bard Inc	FGE	Class II	2001-01-09
K003072	Pacing Leads, Guide Wires, and Various Accessories	BIOTRONIK AG	DTB	Class III	2001-01-09