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 2090 of 3531

510(k) clearances, page 2090 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K951583	Permaquik Bonding Primer	Ultradent Products Inc.	KLE	Class II	1995-05-12
K951530	Prosys Urihesive System La	Convatec, A Division of E.R. Squibb & Sons	EXJ	Class I	1995-05-12
K951526	Trebay Irrgated Cutter Blade	Trebay Medical Corp.	EQJ	Class I	1995-05-12
K951426	American Dental Products (Adp), Visible Light Cure Composite Dental Restorative Material	American Dental Products, Inc.	EBF	Class II	1995-05-12
K951272	Relacs 7000	Micro-Mega Societe Anonyme	ELC	Class II	1995-05-12
K951220	Hema-Glu	Health-Dent Intl., Inc.	KLE	Class II	1995-05-12
K951184	Oti Model 78-60	Oti Medical, LLC	HJO	Class II	1995-05-12
K951181	Ryder Contact Lens Case	Bradstreet Clinical Research Assoc., Inc.	LRX	Class II	1995-05-12
K951168	Crystal	Crystal Optical Co., Ltd.	HQY	Class I	1995-05-12
K951068	Resound Ed4-M Mini-Canal Personal Hearing System W/remote Control Option (Resound Phs Ed4-M)	Resound Corp.	ESD	Class I	1995-05-12
K951067	Resound Ed4-C Canal Personal Hearing System W/remote Control Option (Resound Phs Ed4-C)	Resound Corp.	ESD	Class I	1995-05-12
K950913	Perfect, ENT Set, Praktikant, De Luxe	Rudolf Riester GmbH & Co. KG	ERA	Class I	1995-05-12
K950815	Champion	Kleinfeld, Kaplan and Becker	IOR	Class I	1995-05-12
K950658	Innerdyne Step Trocar Expandable Port, Step:	Innerdyne, Inc.	GCJ	Class II	1995-05-12
K950632	Innerdyne Step Trocar Expandable Port, Step	Innerdyne, Inc.	GCJ	Class II	1995-05-12
K950561	Ksea Disposable Tubing Set for the Arthropump	Karl Storz Endoscopy-America, Inc.	HRX	Class II	1995-05-12
K950501	Danek Rigid Arthroscope	Sofamor Danek USA,Inc.	HRX	Class II	1995-05-12
K950423	Mini Imager	Regulatory Management Services	LMC	Class II	1995-05-12
K946128	Simulix-Hp	Oldelft Corp. of America	KPQ	Class II	1995-05-12
K945907	Karl Storz Semi-Rigid Micro-Endoscopes and Accessories for Adult and Pediatric Endoscopic Urology Procedures	Karl Storz Endoscopy-America, Inc.	FGC	Class II	1995-05-12
K945217	Hydrogel Dressing	O.R. Resources, Inc.	MGQ	Unclassified	1995-05-12
K945193	All-in-One Two Chamber Container	Baxter Healthcare Corporation	KPE	Class II	1995-05-12
K945175	Mechanical Wheelchair 890.3850	Lumex, Inc.	IOR	Class I	1995-05-12
K945153	Mechanical Wheelchair- Lil Dipper	Colours 'N Motion	IOR	Class I	1995-05-12
K945151	Mechanical Wheelchair- G-Force	Colours 'N Motion	IOR	Class I	1995-05-12
K945150	Mechanical Wheerchair- Eclipse	Colours 'N Motion	IOR	Class I	1995-05-12
K945149	Mechanical Wheelchair- Challenger	Colours 'N Motion	IOR	Class I	1995-05-12
K945148	Mechanical Wheelchair- Avenger	Colours 'N Motion	IOR	Class I	1995-05-12
K944262	ECG Monitor	Fukuda Denshi USA, Inc.	DRT	Class II	1995-05-12
K944196	Imwxdop Ir	Imex Medical Systems, Inc.	JAF	Class II	1995-05-12
K943994	Pacs Equipment	Rstar Image Management System	LMD	Class I	1995-05-12
K943939	Non-Contact Tonometer T-2	Canon, Inc.	HKX	Class II	1995-05-12
K943798	Mrh-1500	FUJIFILM Healthcare Americas Corporation	LNH	Class II	1995-05-12
K943714	Micro Multileaf Collimator	Leibinger F.L. Fischer	IYE	Class II	1995-05-12
K943602	Di-2000	Miles Inc., Agfa Division	IYX	Class I	1995-05-12
K943215	Disposable Audiometer Earphone Cushion Cover	Kenneth Ullrich	EWO	Class II	1995-05-12
K942347	Nellcor Symphony Pulse Oximeter Model N-3000	Nellcor, Inc.	DQA	Class II	1995-05-12
K941708	Cobe Centrysystem Cs500 Dialyzer	C.G.H. Medical, Inc.	FJI	Class II	1995-05-12
K922528	Cms System	Micromedical Industries, Ltd.	DQK	Class II	1995-05-12
K951803	Rossiter Sinus Stent	Smith & Nephew Richards, Inc.	KAM	Class I	1995-05-11
K951765	Series 6600 Digital Mobile C-Arm	GE Dec Medical Systems	OXO	Class II	1995-05-11
K951761	Metel Ureteral Basket Stone Dislodger	Annex Medical, Inc.	FFL	Class II	1995-05-11
K951674	Depuy Duraloc 100C Acetabular Cup	Depuy, Inc.	LPH	Class II	1995-05-11
K951601	Med-Tec String Reticle Tray	Medtec LLC	IWE	Class I	1995-05-11
K951528	Amsino Disposable Viginal Speculum	Amsino Intl., Inc.	HIB	Class II	1995-05-11
K951315	Catheterization Table Ks-60	Shimadzu Medical Systems	IZZ	Class II	1995-05-11
K950980	Fast Find Grid	Webb Research, Inc.	KPR	Class II	1995-05-11
K950975	Karl Storz Endovision Twinvideo (Digital Picture-in-Picture Processor) Accessory for Color Television Camera Used in Ens	Karl Storz Imaging, Inc.	FET	Class II	1995-05-11
K950974	Karl Storz Endovision Digivideo (Digital Image Processor) Accessory for Color Television Camera Used in Endoscopic Procs	Karl Storz Imaging, Inc.	FET	Class II	1995-05-11
K950973	Magnetic Resonance Diagnostic System	GE Healthcare	LNH	Class II	1995-05-11