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 2979 of 3529

510(k) clearances, page 2979 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K852151	Photo Curing Light	Dentsply Intl.	EBF	Class II	1985-07-01
K851944	Max-I-Probe Handpiece	Solo Pak Laboratories	EIC	Class I	1985-07-01
K851868	Dahlbert Model De Behing-the-Ear Hearing Aid	Miracle-Ear/Dahlberg, Inc.	ESD	Class I	1985-07-01
K851809	Vacuum Compression Injector	Uci Corp.	KZE	Class II	1985-07-01
K851728	2250/1 to 2285/2 Various Cotton Tweezers	Artiberia	GEN	Class I	1985-07-01
K851708	500/1 to 500/80 Various Types of English Pat Denta	Artiberia	EMG	Class I	1985-07-01
K851659	Skull Mounted Stereotactic Surgical Device	Medco Products, Co., Inc.	HAW	Class II	1985-07-01
K851511	Accuratecare I & Accuratecare II	Sunnex, Inc.	GZJ	Class II	1985-07-01
K851427	Hearing Aid(all in the Ear)	Woodard Hearing Aid Center	ESD	Class I	1985-07-01
K851358	Model Bion 2/Type 90 Room Ionizer	Medicor USA, Ltd.	FRF	Class II	1985-07-01
K851309	Abco Plastic Utensils	Abco Dealers, Inc.	KTC	Class I	1985-07-01
K851261	Alexis	Intex Research & Development Center	ITI	Class II	1985-07-01
K851227	The Enduro	Wheel Ring, Inc.	IOR	Class I	1985-07-01
K851135	Spiro Scan	Brentwood Instruments, Inc.	BZG	Class II	1985-07-01
K851046	Myocare Plus Dual Channel Stimulator	3M Company	IPF	Class II	1985-07-01
K850850	Automove/omnistim IV-Electrical Muscle Stimulator	Physio Technology, Inc.	IPF	Class II	1985-07-01
K850648	Ohmeda Pac Portable Anesthesia System	GE Healthcare	BSZ	Class II	1985-07-01
K845007	Rfa-7 Radiation Field Analyzer	Varian Assoc., Inc.	LHO	Class I	1985-07-01
K844620	Bds-3 Beam Data Scanner	Varian Assoc., Inc.	LHO	Class I	1985-07-01
K844126	Sontec II	Sontec, Inc.	IPF	Class II	1985-07-01
K852563	Pin Set, Bone Rush, 7-1/4 Thru 18-1/2 Inches Long	The Huxley Instrument Corp.	HTY	Class II	1985-06-28
K852562	Pin Set, Bone, Rush, 4 Thru 10 1/2 Inches Long	The Huxley Instrument Corp.	HTY	Class II	1985-06-28
K852561	Pin Set, Bonem, Rush, 1 Thru 10 Inches Long	The Huxley Instrument Corp.	HTY	Class II	1985-06-28
K852560	Pinset, Bone, Rush 9-1/2 Thru 20-3/4 Inches Long	The Huxley Instrument Corp.	HTY	Class II	1985-06-28
K852555	Splintrex	Allison Forge Corp.			1985-06-28
K852531	Non-Perforating Towel Forceps-5-1/4 in Ss 410	The Huxley Instrument Corp.	GEN	Class I	1985-06-28
K852530	Weitianer Mastoid 3 Vs 4 Blunt & Sharp Prongs	The Huxley Instrument Corp.	GAD	Class I	1985-06-28
K852420	Btm Total Hip System	Kirschner Medical Corp.	KWL	Class II	1985-06-28
K852274	Answer	Armkel, LLC	LCX	Class II	1985-06-28
K852201	Echoclonal Hcg Irma	Bio-Rad	JHI	Class II	1985-06-28
K851938	Omnimed Surgical Gown	Omni Intl., Inc.	FYA	Class II	1985-06-28
K851919	Supracondylar Bone Plate	Warsaw Orthopedic, Inc.	KTT	Class II	1985-06-28
K851681	Safestretch Incontinence System	Dbt Medical, Ltd.	KNX	Class II	1985-06-28
K851414	Segmental Spinal Rods	Stuart	KWQ	Class II	1985-06-28
K851374	American Edwards Small Diameter Rigid Endoscope	American Edwards Laboratories	HRX	Class II	1985-06-28
K851257	Crs Ultralite Premier	Everest & Jennings, Inc.	IOR	Class I	1985-06-28
K851256	Mobie Scooter	Everest & Jennings, Inc.	INI	Class II	1985-06-28
K851177	Universal Power Flex	Biodynamic Technologies, Inc.	BXB	Class I	1985-06-28
K850789	Fluted Suction Meniscal Cutter	T. Korossurgical Instruments Corp.	KIJ	Class I	1985-06-28
K850634	Surgidyne Surgiflo C.w.s. Drain Products	Surgidyne, Inc.	GCY	Class I	1985-06-28
K844953	Emit Desipramine Assay	Syva Co.	LFG	Class II	1985-06-28
K844952	Emit Nortriptyline Assay	Syva Co.	LFG	Class II	1985-06-28
K844951	Emit Imipramine Assay	Syva Co.	LFG	Class II	1985-06-28
K844950	Emit Amitriptyline Assay	Syva Co.	LFG	Class II	1985-06-28
K844947	Emit Ancillary Reagents	Syva Co.	KIE	Class I	1985-06-28
K844779	Healthmaster- Model 8320 Motorized Treadmill	Roadmaster Corp.	BXB	Class I	1985-06-28
K844142	Gore-Tex Tissue Matrix	W. L. Gore & Associates, Inc.			1985-06-28
K843533	Cardiac Event Recorder	Cryo2 Corp.	DRT	Class II	1985-06-28
K852488	Controlled Release Infusion System(cris)	Y	FPA	Class II	1985-06-27
K852433	Infusafe 205 Catolog No. 205.000	Medix Medical Electronics (U.S.A.), Inc.	FLN	Class II	1985-06-27