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 2286 of 3531

510(k) clearances, page 2286 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K926224	Diomedics Surgi Light/light Touch Optical Fibers	Diomedics, Inc.	GEX	Class II	1993-07-22
K926049	Digitex, Digitex Hypoallergenic	Mayer Laboratories	LYY	Class I	1993-07-22
K925739	High Speed Dental Drill/handpiece	Feather Touch, Inc.	EFB	Class I	1993-07-22
K925624	Microsurgical Instruments	Mahe-Medizintechnik	GCJ	Class II	1993-07-22
K925378	Steri-Sol Solution, Modification	Anodia Systems	EFB	Class I	1993-07-22
K925375	Consepsis Scrub	Ultradent Products Inc.	LBH	Class II	1993-07-22
K923503	Uric Acid Enzymatic Colorimeric Kit	Randox Laboratories, Limited	KNK	Class I	1993-07-22
K923433	As/3 Anaesthesia Monitoring System Airway Module	Instrumentarium Corp.	CBQ	Class II	1993-07-22
K923157	Dental Rubber Dam	Aseptico, Inc.	EIE	Class I	1993-07-22
K922954	R1, R2, and R1+	Jeneric/Pentron, Inc.	EJH	Class II	1993-07-22
K922805	Nobelpharma Torque Controller	Nobelpharma USA, Inc.	DZE	Class II	1993-07-22
K920362	3M Modular Shoulder System	3M Company	KWS	Class II	1993-07-22
K911592	Steri-Oss Titanium Plama Spray Cylindrical Implant	Steri-Oss, Inc.	DZE	Class II	1993-07-22
K932746	Model T4501,t4502,t4503,t4504,t4504 Tilt Table	Tri W-G, Inc.	INQ	Class I	1993-07-21
K932609	Ear Curette	Ear Tech, Inc.	JYG	Class I	1993-07-21
K932588	Pediatric Temperature Monitoring Circuits	Merit Medical Systems, Inc.	CAI	Class I	1993-07-21
K932583	Adult Temperature Monitoring Anesthesia Circuits	Merit Medical Systems, Inc.	CAI	Class I	1993-07-21
K932486	Pmp, Ltd. Pediatric Temperature Monitoring Circuit	Precision Med Products, Ltd.	CAI	Class I	1993-07-21
K932480	Prism	Bio Clinic Co.	IOQ	Class II	1993-07-21
K932412	Treatment Tables, Electrically Activated	Med Mart, Inc.	INQ	Class I	1993-07-21
K932215	Cowboy III	KCI USA, Inc.	JOW	Class II	1993-07-21
K932094	Bovie Ultrasonic Surgical Aspirator	Mdt Corp., Inc.	LFL	Unclassified	1993-07-21
K931989	Ventri-Cath	Gesco Intl., Inc.	JXG	Class II	1993-07-21
K931635	Treatment Tables, Manually Activated	Med Mart, Inc.	INW	Class I	1993-07-21
K931604	3M Medical Diagnostic Videocassette	3M Company	IWZ	Class I	1993-07-21
K931352	Pedo Jackets or Pj's	George M. Wilson, Dds	ELZ	Class I	1993-07-21
K930888	Wristrecorder Plus Cardiac Event Recording System	Ralin Medical, Inc.	DRS	Class II	1993-07-21
K930232	Cvis Insight Imaging Guide Catheter	Cardiovascular Imaging Systems, Inc.	DQO	Class II	1993-07-21
K926301	Ace Aerosol Enhancer, Hand Held Oral Inhalation Co	Dhd Diemolding Healthcare Div.	CAF	Class II	1993-07-21
K925920	Total Face Mask	Respironics, Inc.	BZD	Class II	1993-07-21
K925285	Dualtherm(r) Cardiac Output Computer	B. Braun of America, Inc.	DQK	Class II	1993-07-21
K925270	Ex N' Flex Ef-200	Tecogics Scientific Ltd	BXB	Class I	1993-07-21
K925161	Nortec Sterile Water for Catheter Balloon Inflatio	North American Sterilization & Packaging Co.	KNY	Class II	1993-07-21
K924929	Reflex(r) Eca	Richard-Allan Medical	HBT	Class I	1993-07-21
K924341	Hayek Oscillator(tm)	Respironics, Inc.	BYT	Class II	1993-07-21
K923276	Capnomac Ultima Anesthesia Monitor	Datex Division Instrumentarium Corp.	CBQ	Class II	1993-07-21
K922876	As/3 Cop Module	Datex Division Instrumentarium Corp.	CBQ	Class II	1993-07-21
K922561	Consensus(tm) Total Hip System	U.S. Medical Products, Inc.	JDL	Class III	1993-07-21
K922393	Emitens Electrodes	Electronic Monitors, Inc.	GXY	Class II	1993-07-21
K915864	Monotrode Cutaneous Electrode	Henley Intl.	GXY	Class II	1993-07-21
K911293	Acufex(r) Tag(tm)	Acufex Microsurgical, Inc.	JDR	Class II	1993-07-21
K932169	Microsurgical Instruments	American Russian Medical Services, Inc.	GZX	Class I	1993-07-20
K932082	Dried Gram-Negative Mic/combo Panels	Baxter Diagnostics, Inc.	JWY	Class II	1993-07-20
K931942	Resound Personal Hearing System Bt-P W/phs Bt-P	Resound Corp.	ESD	Class I	1993-07-20
K931941	Sunscope 100	Sunning Corp.	JAA	Class II	1993-07-20
K931666	Quantikine(tm) Erythropoietin/enz Link Immun Assay	R & D Systems, Inc.	GGT	Class II	1993-07-20
K931605	3M Medical Diagnostic Super Vhs Videocassette	3M Company	IWZ	Class I	1993-07-20
K931498	Solarcare Technologies Corp. Microplate Amp. Assay	Solarcare Technologies Corp,Inc.	DKZ	Class II	1993-07-20
K931295	Iq Tt4 Assay	Becton Dickinson Advanced Diagnostics	CDX	Class II	1993-07-20
K930051	Fathom Cmp-1000	Fathom Ent., Inc.	IYO	Class II	1993-07-20