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 2292 of 3531

510(k) clearances, page 2292 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K931514	Scimed(r) Entre(tm) II Ptca Guide Wire & Accessory	Scimed Life Systems, Inc.	DQX	Class II	1993-06-25
K931310	Glucometer M+ Blood Glucose Meter	Kulzer GmbH	CGA	Class II	1993-06-25
K931303	Woodlyn Operation Microscope	Woodlyn, Inc.	FSO	Class I	1993-06-25
K931142	Instruments for Laparoscopic Use	Li Medical Technologies, Inc.	GCJ	Class II	1993-06-25
K931051	Model 110 Nd:yag Laser	Excel Tech., Ltd.	GEX	Class II	1993-06-25
K931018	Karl Storz 495N Series Fiber Optic Light Cables	Karl Storz Endoscopy-America, Inc.	GCJ	Class II	1993-06-25
K930897	Mi-15 Exam Surgical Light	Medical Illumination, Inc.	FTD	Class II	1993-06-25
K930548	Dpd Defibrillator	Medical Research Laboratories, Inc.	LDD	Class II	1993-06-25
K930511	Stealth Surgical Irrigator Aspirator	W. J. Medical Instruments, Inc.	GCJ	Class II	1993-06-25
K930508	Hiflo Filtered Insufflation Tubing	W. J. Medical Instruments, Inc.	FCX	Class II	1993-06-25
K930497	Argon Handpieces	Beacon Laboratories, Inc.	GEI	Class II	1993-06-25
K930469	Antimicrobial Susceptibility Test Panel	Alamar Biosciences Laboratory, Inc.	JWY	Class II	1993-06-25
K926444	Fujinon Video Laparoscope, Modification	FUJIFILM Healthcare Americas Corporation	GCJ	Class II	1993-06-25
K926390	Predicta Erythropoietin Kit	Genzyme Corporation	GGT	Class II	1993-06-25
K926277	Powder Free Latex Examination Gloves	A.P. Rubber Co., Ltd.	LYY	Class I	1993-06-25
K926098	Digiray	Telescan Corp.	LMD	Class I	1993-06-25
K926010	Surgical Dissector with Cannula	General Surgical Innovations	GCJ	Class II	1993-06-25
K925840	Eclipse 3200	Cardiogenes	GEX	Class II	1993-06-25
K925685	Powder Free Latex Exam Gloves	M.M. Rubber Co., Ltd.	LYY	Class I	1993-06-25
K925633	Balt Introducer	Target Therapeutics	DYB	Class II	1993-06-25
K925450	Bionor Transportmedium	Skoug Research Corp.	JSL	Class I	1993-06-25
K925147	Orc 10.0Mm Suction Probe	O.R. Concepts, Inc.	GCJ	Class II	1993-06-25
K924916	Endopath Endoscopic Tissue Retractor	Ethicon Endo-Surgery Inc	GCJ	Class II	1993-06-25
K924410	Laparoscopic/endoscopic Instrumentation	Core Dynamics, Inc.	GEI	Class II	1993-06-25
K924196	Laparoscopic Needle Holder	Nusurg, Inc.	FHQ	Class I	1993-06-25
K922646	Reference Preparation for Proteins in Human Serum	Behring Diagnostics, Inc.	JIS	Class II	1993-06-25
K921315	Pentax Xenon Light Source	Pentax Precision Instrument Corp.	GCT	Class II	1993-06-25
K921306	Argis Pulmonary Function Testing System	Med Science	BZC	Class II	1993-06-25
K915841	Bard Gauderer Universal Percutaneous Endoscopic	C.R. Bard Inc	KNT	Class II	1993-06-25
K931610	Omnisorb II, Nonwoven Sponge, Sterile and Non	Omni Mfg., Inc.	NAB	Class I	1993-06-24
K930697	Medline Sterile Gauze Sponges	MEDLINE INDUSTRIES, LP - Northfield	NAD	Class I	1993-06-24
K930550	Eco Ligating Clip	Weck Endoscopy	GCJ	Class II	1993-06-24
K926361	Glucometer Encore Qa Blood Glucose Meter	Kulzer GmbH	CFR	Class II	1993-06-24
K926335	Ideas Peanut Wand	Ideal Medical, Inc.	GCJ	Class II	1993-06-24
K926189	Orthoderm Consummate Air Therapy Bed W/scale	Bio Clinic Co.	IOQ	Class II	1993-06-24
K926127	Sure-Closure 75Mm Skin Stretching System	Life Medical Sciences, Inc.	GAG	Class II	1993-06-24
K925839	Trackmaster	Jas Manufacturing Co., Inc.	IOL	Class I	1993-06-24
K925652	Universal Wheelchair Lift	Better Life Medical Technologies, Inc.	INO	Class II	1993-06-24
K925526	Manipler Disposable Skin Stapler	Matsutani Seisakusho Co., Ltd.	GDT	Class I	1993-06-24
K924433	Senior Tech Tabs 88 Trans Ra1/wra1/r1 Ann Type Cr1	Senior Technologies, Inc.	KMI	Class I	1993-06-24
K923999	Alastik Ns	Unitek Corp.	ECI	Class I	1993-06-24
K923541	Body-Mate Massager	American Therapy Products	ISA	Class I	1993-06-24
K922855	Synthes Universal Spine Rod and Screw Fixation Sys	Synthes (USA) Products LLC	KWQ	Class II	1993-06-24
K922502	M32 in the Ear Hearing Aid	Electone, Inc.	ESD	Class I	1993-06-24
K922501	M30 in the Ear Hearing Aid	Electone, Inc.	ESD	Class I	1993-06-24
K921056	Cotrel - Dubousset Spine Implants	Buckman Co., Inc.	KWP	Class II	1993-06-24
K915527	Cps Acetabular Component	Implantology Corp.	JDL	Class III	1993-06-24
K913582	Compatit R	Wilde-USA, Inc.	ELM	Class II	1993-06-24
K932119	Cleveland Tubing, Inc. Ventilator Hoses	Cleveland Tubing, Inc.	BZO	Class I	1993-06-23
K931577	Schneider Magnum Peripheral Recanalization Guidewi	Schneider Intl., Ltd.	DQX	Class II	1993-06-23