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 1841 of 3531

510(k) clearances, page 1841 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K973066	Non-Rebreathing 'T' (Be 117)	Instrumentation Industries, Incorporated	CBP	Class II	1998-02-03
K971756	Medtronic Model 3998 Lead	Medtronic, Inc.	GZB	Class II	1998-02-03
K980028	Alt (Gpt) Liquid Stable 2 Vial - Incorporating Dynamic Stabilization Technology - (Dst)	Trace America, Inc.	CKA	Class I	1998-02-02
K974607	Randox Calcium	Randox Laboratories, Limited	CJY	Class II	1998-02-02
K974508	Dbest One-Step Ovulation Test	Ameritek, Inc.	CEP	Class I	1998-02-02
K974458	Compolute Aplicap	Espe Dental-Medizin GmbH & Co.Kg.	EMA	Class II	1998-02-02
K974413	Permaflo	Ultradent Products Inc.	EBF	Class II	1998-02-02
K974357	Uterine Manipulator/injector	Biomerics	LKF	Class II	1998-02-02
K974163	Minimed Sof-Set Ultimate Qr Infusion Set Models 315 and 316	Medtronic, Inc.	FPA	Class II	1998-02-02
K974027	Auraflex Ft3 150 Test Pack, Auraflex Ft3 Calibrator Pack	Alfa Biotech (Uk), Ltd.	CDP	Class II	1998-02-02
K972657	Ultramist 2000	Texas Medical Industries, Inc.	CAF	Class II	1998-02-02
K972630	Coopersurgical Digital Colposcopy System	CooperSurgical, Inc.	HEX	Class II	1998-02-02
K972119	Maloney Bouge (1210-Xx)/hurst Bougie (1212-Xx)	Medovations, Inc.	FAT	Class II	1998-02-02
K972111	Rumors Dynamic Air Therapy Unit	Hill-Rom Inc.	IKZ	Class II	1998-02-02
K980137	Worldwide Medical Technologies Bone Marrow Biopsy Procedure Tray	Worldwide Medical Technologies, LLC	LRO	Class II	1998-01-30
K980122	Manan Soft Tissue Biopsy Needles	Medical Device Technologies, Inc.	KNW	Class II	1998-01-30
K980030	Ast )Got) Liquid Stable 2 Vial - Incorporating Dynamic Stabilization Technology - (Dst)	Trace America, Inc.	CIT	Class II	1998-01-30
K980005	Manan D Bag	Medical Device Technologies, Inc.	EXF	Class II	1998-01-30
K974886	Powdered Green Nitrile Examination Gloves	Sri Johani Sdn. Bhd.	LZA	Class I	1998-01-30
K974860	Non-Prescription Sunglasses	Wenzhou Ming Ming Optical Co., Ltd.	HQY	Class I	1998-01-30
K974858	Phosphorus-Sl Assay, Catalogue Number 117-10, 117-30	Sekisui Diagnostics P.E.I. Inc.	CEO	Class I	1998-01-30
K974852	Non-Prescription Sunglasses	Chia Hui Spectacles Mfg. Corp.	HQY	Class I	1998-01-30
K974825	Boehringer Mannheim C.f.a.s. - Hdl/ldl-C-Plus	Boehringer Mannheim Corp.	JIX	Class II	1998-01-30
K974777	Vinyl Examination Gloves Powder Free	Sun Flower Gloves Co., Ltd.	LYZ	Class I	1998-01-30
K974577	Compoglass Flow	Ivoclar North America, Inc.	EBF	Class II	1998-01-30
K974440	Ibi	Gallini U.S., LLC	KNW	Class II	1998-01-30
K974392	Leadfix Bioresorbable Membrance Pin System	Biovision, Inc.	DZL	Class II	1998-01-30
K974391	Karl Storz Endovision Xl Endoscopic Camera System	Karl Storz Imaging, Inc.	GCJ	Class II	1998-01-30
K974328	Advance Total Knee System	Wrightmedicaltechnologyinc	JWH	Class II	1998-01-30
K974309	Lactosorb Panels	Zimmer GmbH	HRS	Class II	1998-01-30
K974303	Infant Flow System	Sensor Medics Corp.	BZD	Class II	1998-01-30
K974279	3M Universal Electrosurgical Pad, with Cord (Catalog Number 9135), 3M Universal Electrosurgical Pad, Split with Cord (C)	3M Healthcare	GEI	Class II	1998-01-30
K974138	Rocket Electrode	A & A Medical, Inc.	HGI	Class II	1998-01-30
K974137	Uromed Needle Grasper	Uromed Corp.	OCW	Class II	1998-01-30
K974136	Craniofacial Anchors	Zimmer GmbH	MBI	Class II	1998-01-30
K974126	Imcor 3.75 and 5.00Mm Externally Hexed, Self Tapping Ha Coated Screw Implants with Cover Screw	Imcor	DZE	Class II	1998-01-30
K973814	Trump-It II and Magnum 250	Valley West, Inc.	GCJ	Class II	1998-01-30
K973701	Somnus Tissue Coagulating Electrode	Somnus Medical Technologies, Inc.	GEI	Class II	1998-01-30
K973516	Capiox Hemoconcentrator	Terumo Medical Corp.	KDI	Class II	1998-01-30
K973504	Urosurge Urostent	Princeton Regulatory Assoc.	FAD	Class II	1998-01-30
K973499	Xps Straightshot Microbrider System or Trebay Shaver System	Xomed, Inc.	HRX	Class II	1998-01-30
K972298	Etb Telescope W/working Channel for Seps	The Altomec Corp.	GCJ	Class II	1998-01-30
K972157	Excel Av Stim 1000	Excel Tech., Ltd.	GWJ	Class II	1998-01-30
K971965	Philips Easyvision	Philips North America LLC	LLZ	Class II	1998-01-30
K970445	Vitalmax 4000 Configured/vitalmax 4000 Modular/vitalmax 4100/Minipack 3100/3000/Vitalmax 800+/Minipack 300	Pace Tech Medical Monitors, Inc.	MHX	Class II	1998-01-30
K970119	Mitek Absorbable Polydioxanone (Pds) H Fix	Mitek Products	MBI	Class II	1998-01-30
K980149	Powdered Nitrile Examination Gloves	Masju Sdn. Bhd.	LZA	Class I	1998-01-29
K974887	Powderfree Green Nitrile Examination Gloves	Sri Johani Sdn. Bhd.	LZA	Class I	1998-01-29
K974704	Hydrogum	Zhermack S.p.A.	ELW	Class II	1998-01-29
K974486	Clearfil Liner Bond 2V	Kuraray America, Inc.	KLE	Class II	1998-01-29