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 2047 of 3531

510(k) clearances, page 2047 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K953080	Digital Imaging System Interface	Camtronics, Ltd.	LMD	Class I	1995-09-28
K953028	Titan Driver 60Cc, 30 Minute Administration Set	Halyard Health	MEB	Class II	1995-09-28
K953005	Bili-Meter	Olympic Medical Corp.	JJQ	Class I	1995-09-28
K952655	B & L Electrode	B&L Engineering	IKN	Class II	1995-09-28
K952460	Stryker Acl Interference Screw System	Stryker Corp.	HWC	Class II	1995-09-28
K951737	Argyle Neo-Sert Triple Lumen Umbilical Vessel Catheter Insertion Tray	Sherwood Medical Co.	FOS	Class II	1995-09-28
K945478	Am-50 Aerosol/medication Air Compressor	Preferred Medical Supply, Inc.	BTI	Class II	1995-09-28
K940265	Patton Laparoscopic Catheter Introducer Set	Cook Incorporated	HET	Class II	1995-09-28
K954292	Q5. 5-5.5Npb-2.5Hw	Central Solutions, Inc.	LRJ	Class I	1995-09-27
K954177	Alpha-Bond Dentin Bonding System	Alpha-Bond, Inc.	EMA	Class II	1995-09-27
K954115	Artglass & Kevloc	Kulzer GmbH	EBF	Class II	1995-09-27
K953965	904 Slit Lamp	Clement Clarke, Inc.	HJO	Class II	1995-09-27
K953774	Branemark Restorative Instrument & Component Tray	Nobelpharma USA, Inc.	DZE	Class II	1995-09-27
K953765	Axsym Rea Ethanol	Abbott Medical	DML	Class II	1995-09-27
K953700	Unscented Curved Maxi Pad	Paragon Trade Brands, Inc.	HHD	Class I	1995-09-27
K953666	Unscented Menstral Pad with Wings	Paragon Trade Brands, Inc.	HHD	Class I	1995-09-27
K953405	Hema-Benz	Health-Dent Intl., Inc.	KLE	Class II	1995-09-27
K953381	Prop. Conquest C&b Vlc Glaze/sealant	Jeneric/Pentron, Inc.	EBI	Class II	1995-09-27
K953379	Hypoallergenic Powdered Ambidextrous Coagulatn Dipped Latex Examination Glove	Ansell, Inc.	LYY	Class I	1995-09-27
K953225	Ivac Ball Valce Admin. Sets	Y	FPA	Class II	1995-09-27
K953166	Fuji Bond Lc	GC America Inc.	KLE	Class II	1995-09-27
K953065	Ultrabright (Microquartz Medical Side-Firing Laser Fiber)	Microquartz Medical, Inc.	GEX	Class II	1995-09-27
K953045	Biopro Hemi-Endo Modular Ceramic Head	Biologically Oriented Prostheses	LZO	Class II	1995-09-27
K953006	As/3 Network Link	Datex Medical Instrumentation, Inc.	CCK	Class II	1995-09-27
K952962	Ez-Personal Protection Kit	Safetec of America, Inc.	FXX	Class II	1995-09-27
K952928	Aequalis Shoulder System for Total & Hemishoulder Applications	TORNIER Inc.	KWS	Class II	1995-09-27
K952616	Microtime	Westmed Intl.	BTI	Class II	1995-09-27
K951634	Access Myoglobin Reagents	Bio-Rad Laboratories Inc.	DDR	Class II	1995-09-27
K951260	Urinary Intermittent Catheters W/o Hydromer Hydrophilic Lubricant	Biosearch Medical Products, Inc.	KOD	Class II	1995-09-27
K950204	3I Standard Threaded/self-Tapping Threaded Implants, Miniplants (Tm)	ZimVie US Corp LLC	DZE	Class II	1995-09-27
K944225	Dual Integrator Dental Implant	Implant Integration Systems, Inc.	DZE	Class II	1995-09-27
K942705	E. Coli 0157 Elisa Stool Assay	Lmd Laboratories	GMZ	Class I	1995-09-27
K941228	Endoluminal Access Tube	Med Institute, Inc.	KNT	Class II	1995-09-27
K941145	Oxy-Generator	Med Systems	CAW	Class II	1995-09-27
K933898	Huber Needle Sets	Mediziv Medical Products 1987, Ltd.	FPA	Class II	1995-09-27
K926371	Angled 3.25 Mm Dental Implant Attachments	International Implant Seminars	DZE	Class II	1995-09-27
K953994	Seditainer* Erythrocyte Sedimentation Rate (Esr) System	Becton Dickinson Vacutainer Systems	JKA	Class II	1995-09-26
K953804	Vistakon Multifocal (Etafilcon a) Contact Lens	Vistakon, Johnson & Johnson Vision Products, Inc.	LPL	Class II	1995-09-26
K953610	Aukulyte	Aukland Medical Plastics, Inc.	KPY	Class I	1995-09-26
K953596	Distending Diverticuloscope	Karl Storz Endoscopy-America, Inc.	EOQ	Class II	1995-09-26
K953582	Hfx350, 30Kw, 300Ma, 1 or 3 Phase Radiographic & Fluoroscopic X-Ray Generator	Varian Canada, Inc.	IZO	Class I	1995-09-26
K953577	Bard Visilex Mesh 3 X 6	Davol Inc., Sub. C.R. Bard, Inc.	FTL	Class II	1995-09-26
K953557	Surgical C-Arm Table, 9610	U.S. Imaging Tables, Inc.	IXR	Class II	1995-09-26
K953556	Vacs Table, 9650	U.S. Imaging Tables, Inc.	IXR	Class II	1995-09-26
K953531	Howmedica Mainstay Anchor	Howmedica Corp.	JDR	Class II	1995-09-26
K953420	Silk*skin Scar Treatment	Silk*Skin Care Co.	MDA	Class I	1995-09-26
K952885	Single Lead Digital Telemetry Transmitter	GE Healthcare	DSI	Class II	1995-09-26
K952674	Transact: Attenuation Correction System for the Apex Cardial Gamma Camera	Elscint, Inc.	KPS	Class II	1995-09-26
K950716	Theratest El-Ana Profiles Test System	Theratest Laboratories, Inc.	LJM	Class II	1995-09-26
K945914	Bipolar Generator Model 2352	Richard Wolf Medical Instruments Corp.	GEI	Class II	1995-09-26