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 1829 of 3531

510(k) clearances, page 1829 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K974172	Silgel Topical Gel Sheet	Nagor, Ltd.	MDA	Class I	1998-03-30
K972992	Ceramatec Maxcell and Cag Galvanic Oxygen Sensors	Ceramatec, Inc.	CCL	Class II	1998-03-30
K980769	Windmere Model Ds-2 Foot Bath	Windmere Corp.	ILJ	Class II	1998-03-27
K980758	3 Mm Selec-Tip Laparoscopic Scissors	Microline Pentax, Inc.	GEI	Class II	1998-03-27
K980718	Para-Care	Chattanooga Group, Inc.	IMC	Class II	1998-03-27
K980560	Fotona Skinplus Laser System	Fotona D.D.	GEX	Class II	1998-03-27
K980482	Triangle Sling	Influence, Inc.	OTN	Class II	1998-03-27
K980153	Drug Check	Texas Immunology, Inc.	DIO	Class II	1998-03-27
K980124	Sofsilk Suture	United States Surgical, A Division of Tyco Healthc	GAP	Class II	1998-03-27
K974896	Laserscope El Laser System and Accessories	Laserscope	GEX	Class II	1998-03-27
K974878	E3 Microprobe	Martin Uram, MD	GEX	Class II	1998-03-27
K974877	Cranex Tome Ceph, or Cranex Tome	Orion Corporation Soredex	EHD	Class II	1998-03-27
K974855	Phoresor II, Model Pm900	Iomed, Inc.	KTB	Class II	1998-03-27
K974143	Kmc Newskin	Kmc Intl. Co.	MDA	Class I	1998-03-27
K973652	Duoclipper Titanium Clips	Scion International, Inc.	FZP	Class II	1998-03-27
K972919	Biofix Bioabsorbable Self-Reinforced Poly-L-Lactide Threaded Browlift Screw	Bionx Implants, Inc.	HWC	Class II	1998-03-27
K980902	N-Assay L Ast/got	Crestat Diagnostics, Inc.	CIT	Class II	1998-03-26
K980900	N-Assay Cpk-L	Crestat Diagnostics, Inc.	CGS	Class II	1998-03-26
K973123	Ea-D Igg Elisa Test System	Trinity Biotech USA	LSE	Class I	1998-03-26
K971914	Teca Ncs Electrode System 2000	Medelec, Inc. D.B.A. Teca Corp.	GXY	Class II	1998-03-26
K980806	Affinity Medical Patient Cable System	Affinity Medical Technologies, LLC	DSA	Class II	1998-03-25
K980802	Nitrile Exam Glove, Powder-Free, Blue	Tucker & Associates	LZA	Class I	1998-03-25
K980714	Bci 3401 Handheld Pulse Oximeter	Bci Intl., Inc.	DQA	Class II	1998-03-25
K980564	Medi-Grip (Beige 43)Surgical Gloves	Ansell Perry	KGO	Class I	1998-03-25
K980240	Elecsys Ca 125Ii on the Elecsys 1010	Boehringer Mannheim Corp.	LTK	Class II	1998-03-25
K973419	Dmr Plus Disposable Manual Resuscitator	Medtronic, Inc.	BTM	Class II	1998-03-25
K972300	Cross-Checks P	Steritec Products Mfg. Co., Inc.	JOJ	Class II	1998-03-25
K980574	Auraflex Tsh-3 200 Test Pack Model Number 80600, Auraflex Tsh-3 Calibrator Pack Model Number Number 80601 Auraflex Dil0	Alfa Biotech (Uk), Ltd.	JLW	Class II	1998-03-24
K980301	Ip-16	Servizi Medico Estetici Italinai SRL.	BTA	Class II	1998-03-24
K980230	Quanta Lite B2 Gpi Screen	Inova Diagnostics, Inc.	MSV	Class II	1998-03-24
K980090	Onecath, L-Cath Catheter System, Model Oc-(16-22 Ga., 5Cm-60Cm)	Luther Medical Products, Inc.	LJS	Class II	1998-03-24
K980089	3600 Presure Infusor, Sigmacon 3600, Lapro Flow 3000	Valley West, Inc.	FRN	Class II	1998-03-24
K974906	One Coat Bond Dentin/enamel Adhesive System	Coltene /Whaledent AG	KLE	Class II	1998-03-24
K974828	Branemark System(r) Ebon(tm) Fixture	Nobel Biocare Uas, Inc.	DZE	Class II	1998-03-24
K974737	Astra Tech Implant Dental System	Astra Tech, Inc.	DZE	Class II	1998-03-24
K980722	Trimax Radiographic Cassette	Imation Corp.	IXA	Class II	1998-03-23
K980539	Solobond M	Voco GmbH	KLE	Class II	1998-03-23
K980533	Ero-Scan Otoacoustic Emissions Test Inst. (Er34)	Etymotic Research, Inc.	EWO	Class II	1998-03-23
K980488	Storz Millennium Microsurgicl System High Speed Vitrectomy System	Storz Instrument Co.	HQE	Class II	1998-03-23
K980218	Methafilcon a Soft (Hydrophilic) Contact Lens for Daily Wear	Biocompatibles Eyewear, Inc.	LPL	Class II	1998-03-23
K974819	Selectcells(tm) Mini	Select Medical Systems, Inc.	HHK	Class II	1998-03-23
K974806	Vygon Neo-Sump	Vygon Corp.	KNT	Class II	1998-03-23
K974679	The Tcs-Medcon's Telecardiology System	Medcon, Ltd.	IZI	Class II	1998-03-23
K973740	Round Window E-Cath	Neuro-Biometrix, Inc.	ETD	Class II	1998-03-23
K973548	Mercury Dental	Aleaciones Dentales Zeyco, S.A. de C.V.	ELY	Class II	1998-03-23
K973002	Hurriseal Dentin Desensitizer	Cheng & Assoc., Inc.	KLE	Class II	1998-03-23
K971910	Multi-Parameter Module (M3000a)/display Unit (M3046a)	Hewlett-Packard Co.	DSI	Class II	1998-03-23
K980872	Rapid Drug Screen' 8 Panel	American Bio Medica Corp.	DIO	Class II	1998-03-20
K980666	Infinity Ast Reagent (Procedure No. 51)	Sigma Diagnostics, Inc.	CIT	Class II	1998-03-20
K980119	Acs Hi-Torque Wholey Supra Core Guide Wire	Boston Scientific Corporation	DQX	Class II	1998-03-20