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 2114 of 3531

510(k) clearances, page 2114 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K943971	Kis-II Implant Fixtures	Implant Center of the Palm Beaches	DZE	Class II	1995-03-01
K943968	Tunneler	Denver Biomedicals, Inc.	MDM	Class I	1995-03-01
K943554	Dofi Raster-Screen	Howrey & Simon	GCJ	Class II	1995-03-01
K942984	Bun Reagent	American Research Products Co.	CDQ	Class II	1995-03-01
K942700	Dinamap Vital Signs Monitor Models 9300 and 9320/9340	Critikon Company, LLC	MHX	Class II	1995-03-01
K942378	Pocket Pump	Baxa Infusion Systems	FRN	Class II	1995-03-01
K941547	Cam 4 Thermoelectric Child/adult Mist Tent	Allied Medical LLC	BYK	Class II	1995-03-01
K940898	Model Im77 Intrapartum Fetal Monitor	Advanced Medical Systems, Inc.	HGM	Class II	1995-03-01
K940648	Cordis Disposable Icp Pressure Transducer	Cordis US Corp.	GWM	Class II	1995-03-01
K931845	Sandblaster	Mirage Dental Systems	KOJ	Class II	1995-03-01
K922217	Flexiflo Nasoenteric Feeding Tube	Abbott Medical	KNT	Class II	1995-03-01
K945741	Trocar and Cannula Accessory	Applied Medical Resources Corp	HET	Class II	1995-02-28
K945486	Splatter Control Shield	Taut, Inc.	KKX	Class II	1995-02-28
K945136	Renaguard Dialysate Filter	Medivators Inc	FIP	Class II	1995-02-28
K945098	Op-D-Op II	Op-D-Op Visor Shields, Inc.	LYU	Class I	1995-02-28
K944964	Branemark System Miruscone Abutment System	Nobelpharma USA, Inc.	DZE	Class II	1995-02-28
K944863	Compel Surgicaldrapes	Standard Textile Co., Inc.	KKX	Class II	1995-02-28
K944859	Orex Surgical Drapes	Thantex Specialties, Inc.	KKX	Class II	1995-02-28
K944827	Orex Surgeon's Gown	Thantex Specialties, Inc.	FYA	Class II	1995-02-28
K944069	Restore Tps Lhex Cylinder Endosseous Implant System	Lifecore Biomedical LLC	DZE	Class II	1995-02-28
K943201	Clean Air	CooperSurgical, Inc.	GEX	Class II	1995-02-28
K943143	Biliary Stent	Menlo Care, Inc.	FGE	Class II	1995-02-28
K942918	Tri-Med Endoscopic Fluid Introduction Catheter	Tri-Med Specialties, Inc.	OCX	Class II	1995-02-28
K942112	Karl Storz Flexible Choledochoscope	Karl Storz Endoscopy-America, Inc.	FBN	Class II	1995-02-28
K941557	Disposable Latex Exam Gloves	Dah Lee Investments, Ltd.	LYY	Class I	1995-02-28
K941472	Cervex-Brush Pap Kit	Rovers Diagnostic Devices	HHT	Class II	1995-02-28
K932276	CO2 Hydromat Pump for Irrigation, Model #26310020	Karl Storz Endoscopy-America, Inc.	HET	Class II	1995-02-28
K950636	Olympus Disposable Biopsy Forceps	OLYMPUS Corporation of the Americas	EOQ	Class II	1995-02-27
K950603	Karl Storz Viscous Fluid Injection Set	Karl Storz Endoscopy-America, Inc.	EOB	Class II	1995-02-27
K950381	Oticon/logic	Oticon, Inc.	ESD	Class I	1995-02-27
K950374	Fossil Partners, L.p. (Fossil)	Strasburger & Price, L.L.P.	HQY	Class I	1995-02-27
K950334	Karl Storz Tele-Scrub	Karl Storz Endoscopy-America, Inc.	EOB	Class II	1995-02-27
K950252	Champro/united Athletic	Wilson Hunt Intl./, Ltd.	HQY	Class I	1995-02-27
K950241	Ophthalmic Sponges	Oasis Medical, Inc.	HOZ	Class II	1995-02-27
K950109	Cypress Medical Products Catheter (Insertion) Tray/with Out Catheter	Cypress Medical Products LLC	FCM	Class II	1995-02-27
K950092	Cypress Medical Products Catheter (Insertion) Tray	Cypress Medical Products LLC	FCM	Class II	1995-02-27
K946203	Jai Powderfree Latex Examination Gloves	Intl. Trade Management Co.	LYY	Class I	1995-02-27
K946194	Wee Bag O'mercury	MicroSurgical Technology Inc	LCC	Class II	1995-02-27
K946031	Dermassist(tm) Hydrogel Saturateed Non Woven Dressing	Wilshire Medical Products	MGQ	Unclassified	1995-02-27
K946030	Dermassist(tm) Hydrogel Saturated Gauze Dressing	Wilshire Medical Products	MGQ	Unclassified	1995-02-27
K946015	Ivalon External Sponge	Ivalon	NAB	Class I	1995-02-27
K945871	R&d Part Nos. 5339, 5510, 5514	R & D Batteries, Inc.	FCO	Class I	1995-02-27
K945869	R&d Part Nos. 5443, 5322, 5448, 5492	R & D Batteries, Inc.	FCO	Class I	1995-02-27
K945802	Dermagran Wound Cleanser with Zinc	Derma Sciences, Inc.	KMF	Class I	1995-02-27
K945729	Dynamicaire(tm) Sleep Surface, Zoneair(tm) Sleep Surface	Hill-Rom Inc.	IOQ	Class II	1995-02-27
K945451	Hi Dense, Glass Ionomer Silver Reinforced Restorative	Shofu Dental Corp.	EMA	Class II	1995-02-27
K945449	Unicath Llu Angiographic System	Xre Corp.	IZI	Class II	1995-02-27
K945407	Ssvo Phonate(tm) Shiley Speaking Valve with Oxygen Port	Mallinckrodt Medical Tpi, Inc.	BTO	Class II	1995-02-27
K945406	Ssv Phonate(tm) Shiley Speaking Valve	Mallinckrodt Medical Tpi, Inc.	BTO	Class II	1995-02-27
K945221	Sutter Model 6000 Hand Cpm Device	Sutter Corp.	BXB	Class I	1995-02-27