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 2324 of 3531

510(k) clearances, page 2324 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K922280	Illuminator VII Mini/lum Light	Medical Illumination, Inc.	KZF	Class I	1993-02-05
K922277	Illuminator II	Medical Illumination, Inc.	KZF	Class I	1993-02-05
K921837	Medicam 900 Insufflator with Accessories	Kirschner Medical Corp.	HIF	Class II	1993-02-05
K921450	Non-Invasive Tubing	Specialty Medical Sales, Inc.	FPK	Class II	1993-02-05
K921215	Laserstar Imager	Frantz Imaging, Inc.	LMC	Class II	1993-02-05
K920234	Davol Laparoscopic Dissectors	C.R. Bard Inc	HET	Class II	1993-02-05
K911611	System Athena, Modification	S & W Medico Teknik	DRT	Class II	1993-02-05
K924629	Pap Antibody Kit	Ventana Medical Systems Inc	DFD	Class II	1993-02-04
K924069	Surgico Oxygen Mask	Gujarat Surgico, Ltd.	BYG	Class I	1993-02-04
K923860	The Galileo Line -- Planet 100, 200 & 300 & Star	Biosound, Inc.	GWQ	Class II	1993-02-04
K926320	Reflab System Pack Liquid CO2 Reagent	Medical Analysis Systems, Inc.	CHS	Class II	1993-02-03
K926055	The Miller Nebulizer System	Warren C. Miller	CAF	Class II	1993-02-03
K925492	Biomerieux Hemolab Thrombomat	Biomerieux Vitek, Inc.	GJS	Class II	1993-02-03
K924249	Dermassist Transparent Site Dressing	Wilshire Medical Products	KMK	Class I	1993-02-03
K924218	Bac-T-Screen	Biomerieux Vitek, Inc.	JXA	Class I	1993-02-03
K923696	Cordis Viera Guidewire	Cordis US Corp.	DQX	Class II	1993-02-03
K922368	Periflux Pf4001 Laser Doppler Flowmeter	Perimed AB	DPW	Class II	1993-02-03
K922119	Model 5002 Lift Weigh-Scale	Acme Medical Scale Co.	FRW	Class I	1993-02-03
K913474	Respire Disposable Pulmonary Resuscitator	Med-Tek Innovations, Inc.	BTM	Class II	1993-02-03
K926476	Soundchoice with Variable Slope	Bausch & Lomb Incorporated	ESD	Class I	1993-02-02
K926204	Sas One Step Pregnancy	SA Scientific, Ltd	JHI	Class II	1993-02-02
K926085	Widex Model D16	Widex Hearing Aid Co., Inc.	ESD	Class I	1993-02-02
K925845	Vista Hp/hpq System	Philips North America LLC	LNH	Class II	1993-02-02
K925684	Olymp-X,x-Ray Generator	Afp Imaging Corp.	IZO	Class I	1993-02-02
K925585	Gsi 38 Auto Tymp	Lucas Grason-Stadler, Inc.	ETY	Class II	1993-02-02
K925541	Stockert 1/4 Bubble Sensor	Sorin Biomedica, Fiat, USA, Inc.	KRL	Class II	1993-02-02
K925263	Meridian Medical Systems Connectors & Airway Ext	Merit Medical Systems, Inc.	BZA	Class I	1993-02-02
K925197	Psi 220 Dual EMG	Fasstech	HCC	Class II	1993-02-02
K925118	En Typing Cie Kit for Diagnostic Use	The Binding Site	LLL	Class II	1993-02-02
K924178	Medvision(tm) Imaging Software	Evergreen Technologies, Inc.	LMD	Class I	1993-02-02
K923709	Memory Wire	Wire Products	EJF	Class I	1993-02-02
K923077	Advantage Windows 3D Option and Dentascan Option	GE Healthcare	JAK	Class II	1993-02-02
K922944	Immuchem Lh-Mw Elisa	Icn Biomedicals, Inc.	CEP	Class I	1993-02-02
K922575	Always Contours Unscented Menstrual Pads	Procter & Gamble Co.	HHD	Class I	1993-02-02
K922267	Photophone(r) Multi View(tm)	Image Data Corp.	LLZ	Class II	1993-02-02
K915423	Hemo-Cath Silicone Access Catheter	Medical Components, Inc.	LFJ	Class II	1993-02-02
K915157	Powder Free Examination Glove	American Pro Latex, Inc.	LYY	Class I	1993-02-02
K930145	Phonak Piconet 231-X	Phonak, Inc.	ESD	Class I	1993-02-01
K925749	Kendall Tru-Close(tm) Suction Reservoir, 150 Ml	Kendall Healthcare Products Co. Div.Of Tyco Health	GCY	Class I	1993-02-01
K925598	Buckymatic Automatic Chest Film Changer	Acoma Medical Imaging, Inc.	KPX	Class II	1993-02-01
K925033	Stille Automatic Tourniquet	Ferguson Medical	KCY	Class I	1993-02-01
K924984	Specialist(r) Walker	Johnson & Johnson Orthopaedics, Inc.	FYH	Class I	1993-02-01
K924090	The Endo Optiks Microprobe	Endo Optics, Inc.	HQB	Class II	1993-02-01
K923865	5701, 5702, 5704, 5706 Hygroscopic Condenser Humid	Vital Signs, Inc.	BYD	Class I	1993-02-01
K923463	Clostridium Difficile Toxin/antitoxin Kit	Techlab, Inc.	LLH	Class I	1993-02-01
K922123	Auto Suture Disposable Endoscopic Specimen Pouch	United States Surgical, A Division of Tyco Healthc	GCI	Class II	1993-02-01
K920357	Ultracell Ear Wick	Ultracell Medical Technologies, Inc.	KCN	Class I	1993-02-01
K920121	Sechrist IV-100B Savi System	Sechrist	CBK	Class II	1993-02-01
K925532	Powder Free Examination Gloves	Mbf Health Products Bhd. Sdn.	LYY	Class I	1993-01-29
K925108	Integrated Visualization System	Neuro Navigational Corp.	FWF	Class I	1993-01-29