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 2377 of 3531

510(k) clearances, page 2377 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K920769	Konica Li 10 and 10A Laser Imager	Konica Corp.	LMC	Class II	1992-05-06
K920711	Entrac Urethral Balloon Dilatation Catheter	American Medical Systems, Inc.	KOE	Class II	1992-05-06
K920643	Laparoscopic Suction/irrigation Probe	O.R. Concepts, Inc.	GBZ	Class I	1992-05-06
K920547	Ultra-Thin	Boston Scientific Corporation	LIT	Class II	1992-05-06
K920263	Manual Surgical Instruments	Phoenix Instruments Div.	KDC	Class I	1992-05-06
K920236	Cholangiogram Catheter Kit	Mccol Medical,Inc.	FGE	Class II	1992-05-06
K915446	Stretch Wrap	Sun Glitz Corp.	KGX	Class I	1992-05-06
K914991	Versapulse(tm) Twopointone/xe Holmium Surg Lasers	Coherent Medical Group	GEX	Class II	1992-05-06
K914836	Omron Compressor Nebulizer- Model Ne-C09	Omron Healthcare Co., Ltd.	CAF	Class II	1992-05-06
K914190	Auto Suture(r) Endoscopic Fan Retractor	United States Surgical, A Division of Tyco Healthc	GAD	Class I	1992-05-06
K921626	Teletom(r)	Berchtold Holding GmbH	FQO	Class I	1992-05-05
K921464	Cat.#40100, 40102, 40104 & 40106 Yankauer Suct Int	Trinity Laboratories, Inc.	GBQ	Class I	1992-05-05
K921245	The Bracket Assembly W/ Security System II	Ormco Corp.	DYH	Class II	1992-05-05
K921117	Minidam	Delsan Dental Systems	DYN	Class I	1992-05-05
K920922	Gdc 3367	Deringer-Ney, Inc.	EJS	Class II	1992-05-05
K920102	The Selby System	Advanced Spine Fixation Systems, Inc.	KWP	Class II	1992-05-05
K915507	E-Z Gold Tooth Filling Material	Lloyd Baum Center, Inc.	EJT	Class II	1992-05-05
K915119	Scalpel Blade Remover (Bladegard)	Intergrated Visual, Inc.	GES	Class I	1992-05-05
K914615	Btp(tm) Centraline(tm) Suit	Btp Industries, Inc.	FXO	Class I	1992-05-05
K914152	Sidestream Drug Nebulizer	Medic-Aid, Ltd.	CAF	Class II	1992-05-05
K913688	Bud Maxillofacial Implant System	Bud Industries, Inc.	JEY	Class II	1992-05-05
K912145	System Athena-Product Enhancements, Anesthesia	S & W Medico Teknik	CCE	Class II	1992-05-05
K921752	Ambulator	The Anthros Medical Group	INM	Class I	1992-05-04
K921648	Bruno Electra-Ride Stair-Way Elevator System	Bruno Independent Living Aids, Inc.	ILK	Class II	1992-05-04
K921647	Regal Motorizied 3 Wheeled Vehicle	Bruno Independent Living Aids, Inc.	INI	Class II	1992-05-04
K921554	Amphetamines Eia Test	Diagnostic Reagents, Inc.	DKZ	Class II	1992-05-04
K921351	Jace Model Pm-410 Hand Cpm Device	Jace Systems, Inc.	JFA	Class I	1992-05-04
K920710	Air Medica III	Hinatawada Seimitsu Mfg. Co., Ltd.	EIA	Class I	1992-05-04
K920515	Insertion	Accurate Surgical Instruments Co.	FJS	Class II	1992-05-04
K915896	Microlite Microtiter Plate Luminometer Ml2250/modi	Dynatech Laboratories, Inc.	JJQ	Class I	1992-05-04
K915479	Captia Cmv-Ta	Mercia Diagnostics, Ltd.	LFZ	Class II	1992-05-04
K915210	Electro-Nerve Stimulator TENS Model Micro Plus-a	BioMedical Life Systems Inc.	GZJ	Class II	1992-05-04
K912391	Rubalex, Modification	Orion Corp.	LQN	Class II	1992-05-04
K911233	Chagas' Igg Elisa Test	Gull Laboratories, Inc.	MIU	Class I	1992-05-04
K911202	Atraumatic Standard Sprotte Needle	Pajunk GmbH Medizintechnologie	BSP	Class II	1992-05-04
K920499	Sani-Tip	Dw Industries, Inc.	ECB	Class I	1992-05-03
K921269	Kodak X-Omat Model 180 Lp Processor	Eastman Kodak Company	IXW	Class II	1992-05-01
K920213	Mitek Anchor, Mitek Anchor II	Mitek Surgical Products, Inc.	JDR	Class II	1992-05-01
K920211	Sun/sportglasses	Bacou USA, Inc. and Uvex Safety, Inc.	HQY	Class I	1992-05-01
K920169	Sunglasses	Walgreen Co.	HQY	Class I	1992-05-01
K920147	Thrombin Clotting Time Reagent	Helena Laboratories, Corp.	GJA	Class II	1992-05-01
K920088	Camino Ventricular Needle	Camino Laboratories, Inc.	HCD	Class I	1992-05-01
K914856	Vascular Catheter & Wire Guides W/medi-Coat(tm)	Cook Inc.	DQY	Class II	1992-05-01
K914620	Hms-4000 Physiological Monitor, Modification	Vitalog Monitoring,Inc.	DQA	Class II	1992-05-01
K914256	Yellow Iris Urinalysis Wrksta W/iriscope Bdy Flu	Intl. Remote Imaging Systems	GKL	Class II	1992-05-01
K914205	Pff-1	Cybermedic, Inc.	BZG	Class II	1992-05-01
K913342	Autostat(tm) Anti-Dsna	Cogent Diagnotics, Ltd.	LKJ	Class II	1992-05-01
K912640	Concept Endosteal Fixation Device	Concept, Inc.	HWC	Class II	1992-05-01
K921829	Rionet Hearing Aid Hb-52S	Authorized Hearing Systems, Inc.	ESD	Class I	1992-04-29
K921817	Rifton Mor219 19 & Rifton Mor225 25	Rifton Equipment for the Handicapped	INM	Class I	1992-04-29