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 2026-11-02, 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 964 of 3531

510(k) clearances, page 964 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K110450	Agilis Nxt Steerable Introducer	Abbott Medical	DYB	Class II	2011-05-10
K110399	Gladiator Plasma Classic Hip Stem	Wrightmedicaltechnologyinc	KWA	Class III	2011-05-10
K110386	Celox Rapid Gauze	Medtrade Products Ltd.	QSY	Unclassified	2011-05-10
K110314	Stretch Vinyl Examination Glove, Powder Free (Yellow/white/clear(non-Colored)	True Glove Factory	LYZ	Class I	2011-05-10
K110121	Wexler Endoscope Accessories	Microsurgical Laboratories,Inc.Dba Wexler Surgical	GCJ	Class II	2011-05-10
K103718	Dynacor Lubrication Gel	MEDLINE INDUSTRIES, LP - Northfield	KMJ	Class I	2011-05-10
K102860	Alcon Multi-Pirpose Disinfecting Solution	Alcon Laboratories	LPN	Class II	2011-05-10
K102788	Tornier Biofiber Scaffold	TORNIER Inc.	FTL	Class II	2011-05-10
K102725	Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model M-1000, Stingray Guidewire Model M-3004 and M	Bridge Medical, Inc.	DQY	Class II	2011-05-10
K101585	K-Y Brand Long Lasting Vaginal Moisturizer	Johnson & Johnson Consumer & Personal Products Wor	NUC	Class II	2011-05-10
K100567	Pearl Diabetes Management System	M2 Group Holdings, Inc.	LZG	Class II	2011-05-10
K110751	Codman Bactiseal Endoscopic Venticular Catheter	Cerenovus, Inc.	JXG	Class II	2011-05-09
K103611	Urology Monopolar Snare for Tissue Transection	United States Endoscopy Group, Inc.	FDI	Class II	2011-05-09
K102182	Maquet Flow-I C20, Maquet Flow-I C30, Model 66 77 200, 66 77 30	Maquet Critical Care AB	BSZ	Class II	2011-05-09
K101763	Diopsys Nova Vep Vision Testing System	Diopsys Inc	GWE	Class II	2011-05-09
K092266	Randox Methamphetamine Assay	Randox Laboratories, Limited	DKB	Class II	2011-05-09
K111164	Eunity	Client Outlook, Inc.	LLZ	Class II	2011-05-06
K111015	Sterile Latex Powder Free Surgical Gloves with Hydrogel Coating	Medtronic, Inc.	KGO	Class I	2011-05-06
K110788	Innova Wheelchair	Columbia Medical Manufacturing, LLC	IOR	Class I	2011-05-06
K110396	Aspira Peritoneal Drainage System	C.R. Bard Inc	PNG	Class II	2011-05-06
K110369	Indistrip Green	Indilab, Inc.	JOJ	Class II	2011-05-06
K110257	Diamond-Flex(r) Graspers	Medtronic, Inc.	GCJ	Class II	2011-05-06
K103771	Lotus Blake Esteem Scooter	Letrix Power Hangzhou Pty, Ltd.	INI	Class II	2011-05-06
K103730	Ge Lunar Visceral Fat Software	GE Medical Systems Ultrasound and Primary Care Dia	KGI	Class II	2011-05-06
K103510	Unimax Specimen Retrieval System	Unimax Medical Systems Inc.	GCJ	Class II	2011-05-06
K103364	Mission Clinicheck Assayed Chemistry Controls, Level 1, Level 2, Dual Level	DIAMOND DIAGNOSTICS Inc	JJY	Class I	2011-05-06
K103174	Apex Medical Wizard Series CPAP Mask	Apex Medical, Inc.	BZD	Class II	2011-05-06
K102913	Forcetriad	Covidien, Formerly Valleylab, A Division of Tyco H	GEI	Class II	2011-05-06
K102568	Uric Acid Model 3P39	Abbott Medical	KNK	Class I	2011-05-06
K102208	Nanogen	Orthogen Corp.	LYC	Class II	2011-05-06
K102141	Cook Word Bartholin Gland Catheter (Final Trade Name Not Yet Determined)	Cook Incorporated	KNA	Class II	2011-05-06
K101158	Lic Instrument Processing System	Langford IC Systems, Inc.	FEB	Class II	2011-05-06
K100263	Elitech Clinical Systems Phosphorus, Uric Acid Mono Sl and Urea UV Sl Reagents	VitalScientific	CEO	Class I	2011-05-06
K111185	Relyx Luting Plus Automix	3M ESPE Dental Products	EMA	Class II	2011-05-05
K111102	Radiovision	Haas Software	LLZ	Class II	2011-05-05
K111099	Issys Lp Spinal Fixation System	Custom Spine, Inc.	NKB	Class II	2011-05-05
K110973	Ie-Zen (in Clear Series Hearing Aid)	Widex USA	KLW	Class II	2011-05-05
K110963	Ellipse Occipito-Cervico-Thoracic Spinal System	Globus Medical, Inc.	KWP	Class II	2011-05-05
K110875	Centricity Pacs	GE Healthcare	LLZ	Class II	2011-05-05
K110593	Owl RF Probes	Diros Technology, Inc.	GXI	Class II	2011-05-05
K110549	Ensite Velocity System	Abbott Medical	DQK	Class II	2011-05-05
K110358	Venodyne V810	Microtek Medical LLC	JOW	Class II	2011-05-05
K103835	Reunion Tsa System-Humeral Press-Fit & Cemented Stems Model 5569-Yy-20Xx (Yy=p,c; Xx=07-17,06L-12L) Reunion Tsa System N	Howmedica Osteonics Corp	KWS	Class II	2011-05-05
K103760	Titan	Interacoustics a/S	GWJ	Class II	2011-05-05
K102342	Keypath(tm) Mrsa/mssa Blood Culture Test- Bt	Microphage, Inc.	OUS	Class I	2011-05-05
K102263	Horizon Perinatal Care Surveillance and Archival Model Verson 4.0	Mckesson Information Solutions, LLC	HGM	Class II	2011-05-05
K094013	Hls Kneetec System	TORNIER Inc.	JWH	Class II	2011-05-05
K110440	Quick Up	Voco GmbH	EBI	Class II	2011-05-04
K110438	Sensilase Pad-Iq	Vasamed, Inc.	DPW	Class II	2011-05-04
K103764	Reveal Xt Insertable Cardiac Monitor, Model 9529 and Reveal Dx Insertable Cardiac Monitor, Model 9528	Medtronic, Inc.	DSI	Class II	2011-05-04