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 2424 of 3531

510(k) clearances, page 2424 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K911944	Medi Guard Dental Bib	Sancella, Inc.	KKX	Class II	1991-10-04
K911846	Uri-Three(tm), Modification	Culture Kits, Inc.	JXA	Class I	1991-10-04
K911768	Amset(tm) Bone Screw	Advanced Med/Surg, Inc.	HWC	Class II	1991-10-04
K910681	Simmons Plating System	Smith & Nephew Richards, Inc.	KWQ	Class II	1991-10-04
K910585	Tsir Angled Abutments	Core-Vent Corp.	DZE	Class II	1991-10-04
K913021	Biodex,model B-2000	Biodex Corp.	IKK	Class II	1991-10-03
K913020	Biodex System 2,Model S2-S	Biodex Corp.	IKK	Class II	1991-10-03
K912931	Itm Sonic Surgery System	Buckman Co., Inc.	JDX	Class II	1991-10-03
K911402	Model #350 Shock-Plate Defib Adaptor	Cardiotronics, Inc.	LDD	Class II	1991-10-03
K910323	Bedside Fluid Management System 1000 (Fms-1000)	UAB Research Foundation	FLN	Class II	1991-10-03
K914069	Reflab(tm) Brand Syst Pk Liq Reagent, Apolipop a-1	Medical Analysis Systems, Inc.	MSJ	Class I	1991-10-02
K914068	Abbott Quickstart Asparate Aminotransferase Test	Em Diagnostic Systems, Inc.	CIT	Class II	1991-10-02
K913892	Fasttech System II	3M Diagnostic Systems, Inc.	DHB	Class II	1991-10-02
K913806	Ysi Model 2300 Stat Plus	Ysis, Inc.	CGA	Class II	1991-10-02
K913455	Oxygen Masks 82400 & 82405	Specialty Packaging Producs, Inc.	BYG	Class I	1991-10-02
K913402	Perry(r) Dermaguard(r) Plus Gloves	Smith & Nephew Perry	KGO	Class I	1991-10-02
K913388	The Pan.optx Sportglass	Panoptx, Inc.	HQY	Class I	1991-10-02
K913230	Unidirectional Occluder	Welch Allyn Inc	HOY	Class I	1991-10-02
K913100	Palfique Inlay	Tokuyama America Inc.	EBF	Class II	1991-10-02
K913099	Palfique Liteposterior	Tokuyama America Inc.	EBF	Class II	1991-10-02
K913069	Dw238 #228-04B	Ivoclar North America, Inc.	EJS	Class II	1991-10-02
K913068	Dw238 #228-34A	Ivoclar North America, Inc.	EJS	Class II	1991-10-02
K913047	Sterilesert(tm) Cable and Pole Drape	Arch Development Group	KKX	Class II	1991-10-02
K913023	Skintemp	Biocore	KGN	Unclassified	1991-10-02
K913019	Pdi Parallel Sided Post Kit	Precident Corp.	ELR	Class I	1991-10-02
K912769	Patient Lift and Transport	Century Manufacturing Co.	FNG	Class II	1991-10-02
K912731	Steri-Swab	Westlock Investments (USA), Inc.	LKB	Unclassified	1991-10-02
K912715	Instant Warm Gel Pack	Prism Technologies, Inc.	IMD	Class I	1991-10-02
K912593	Modular Hip System	Smith & Nephew Richards, Inc.	JDI	Class II	1991-10-02
K912563	Angel Wing Safety Blood Collection and Infusion Se	Mbo Laboratories, Inc.	FOZ	Class II	1991-10-02
K912472	Deroyal Wound Dressing	DeRoyal Industries, Inc.	MGO	Class I	1991-10-02
K912468	Liatest Protein S Kit	American Bioproducts Co.	GGP	Class II	1991-10-02
K912429	N80-838 Supramid Extra Suture	S. Jackson, Inc.	GAR	Class II	1991-10-02
K912367	Eye Bubble	Apyx Medical Corporation	HOY	Class I	1991-10-02
K911758	Amish Country Spa	Fox Pool Corp.	ILJ	Class II	1991-10-02
K911574	Pneu-Wave	Pneu-Mobility, Inc.	JFB	Class II	1991-10-02
K910972	Walter Graphtek	Inomed Medizintechnik GmbH	GWQ	Class II	1991-10-02
K903480	Hann-Vac Tm, Disposable,suction Catheter	Un-I-Med, Inc.	BSY	Class I	1991-10-01
K914107	Prolactin Irma Immunomag	Pantex, Div. Bio-Analysis, Inc.	CFT	Class I	1991-09-30
K913840	Microtak Plus	Syva Co.	JJQ	Class I	1991-09-30
K913663	Aia-Pack T-U	Tosoh Corp.	KHQ	Class II	1991-09-30
K913603	Fibretwins	Oral-B Laboratories	KNT	Class II	1991-09-30
K913574	Septocal Cavity Liner	Specialites Septodont	EJK	Class II	1991-09-30
K913469	Endopath Disposable Endoscopic Multifeed Stapler	Ethicon, Inc	GCJ	Class II	1991-09-30
K913248	Cytology Brush	Annex Medical, Inc.	FDX	Class II	1991-09-30
K913152	Whiter Biter Crown	George M. Wilson, Dds	ELZ	Class I	1991-09-30
K913140	Silicone Gel Sheeting	Cui Corp.	MDA	Class I	1991-09-30
K913087	Dental Floss	Westone Products, Ltd.	JES	Class I	1991-09-30
K913030	Max-I-Probe Irrigation System	Smith & Nephew, Inc.	EFS	Class I	1991-09-30
K912963	Instrumentarium Mega4	Instrumentarium Imaging, Inc.	LNH	Class II	1991-09-30