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 2113 of 3531

510(k) clearances, page 2113 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K945892	Silon(r) Silicone Thermoplastic Sheeting	Bio Med Sciences, Inc.	MDA	Class I	1995-03-03
K945558	Premier(tm) H. Pylory	Meridian Diagnostics, Inc.	LYR	Class I	1995-03-03
K945494	Wallstent(r) Tracheobronchial Endoprosthesis	Boston Scientific Corporation	JCT	Class II	1995-03-03
K945135	Microplate Processor 3000	bioMerieux, Inc.	JJE	Class I	1995-03-03
K945129	Scimed Chioce Plus Ptca Guide Wire	Scimed Life Systems, Inc.	DQX	Class II	1995-03-03
K944668	Sherpa Sherpa II and Ascent Coronary Guiding Catheters	Medtronics Interventional Vascular	DQY	Class II	1995-03-03
K944284	Control	Daig Corp.	DQO	Class II	1995-03-03
K943771	Medx Reusable Sharps Container	Bfi- Medical Waste Systems	FMI	Class II	1995-03-03
K942864	Lung Diffusion	Nordan Smith Welding Supplies	BZC	Class II	1995-03-03
K933848	Prespo 7, Self-Sufficient Drip Device	Bonding Corp.	FPA	Class II	1995-03-03
K950732	Manan Super-Core Biopsy Needle	Argon Medical Devices, Inc	KNW	Class II	1995-03-02
K950609	Orvis Key West Sunglasses	The Orvis Co., Inc.	HQY	Class I	1995-03-02
K950608	Digital Spot Mammography for Sterotactic Application	Lorad Corp.	IZH	Class II	1995-03-02
K950599	Stors Scleral Sponge II (Lincoff Design)	Storz Ophthalmics, Inc.	HQX	Class II	1995-03-02
K950526	Sunglasses	Tony Optical Enterprises Co., Ltd.	HQY	Class I	1995-03-02
K950519	Silhouette Sunlimited Adidas	Silhouette Optical Ltd.	HQY	Class I	1995-03-02
K946331	Karl Storz Bougies, Sounds, Dilators	Karl Storz Endoscopy-America, Inc.	EOX	Class II	1995-03-02
K946117	Medical Image Management System (Mim)	Siemens Medical Solutions Health Services Corporat	LLZ	Class II	1995-03-02
K945895	Metal Frame, Plastic Frame	Sun Vista Intl., Inc.	HQY	Class I	1995-03-02
K945877	Weco Endoscopic Systems with Fiber Optic Light	Wells Johnson Co.	HJM	Class II	1995-03-02
K945767	Powder Free, Hypoallergenic Ambidextrous Patient Examination Gloves	Ansell, Inc.	LYY	Class I	1995-03-02
K945060	Hernia Mesh Introduction System	Gerard Medical, Inc.	FTL	Class II	1995-03-02
K944488	S & S Orthopedic Wire Driver 701	S & S Orthopedic, Ltd.	KIJ	Class I	1995-03-02
K944466	Sealdent	Scientific Pharmaceuticals, Inc.	EBI	Class II	1995-03-02
K944387	R&d Batteries Part Nos. 5186 and 5230	R & D Batteries, Inc.	FCO	Class I	1995-03-02
K943197	Kt1000/s Knee Ligament Arthrometer	Medmetric Corp.	LYH	Class I	1995-03-02
K942296	V5m	Acuson Corp.	ITX	Class II	1995-03-02
K941961	605 Vacu-Max	Medical Industries America, Inc.	BTA	Class II	1995-03-02
K935595	Acuson Model 3001	Acuson Corp.	ITX	Class II	1995-03-02
K950720	Kbtc	Kyong-Buk Trading Corp.	HQY	Class I	1995-03-01
K950635	Candeka Dukatir Sets	Candela Corporation	DQY	Class II	1995-03-01
K950634	Candela Sheath Sets	Candela Corporation	DQY	Class II	1995-03-01
K950456	Martin Sunglasses	Jack Martin Co., Inc.	HQY	Class I	1995-03-01
K950449	Surgical Bur	Transidyne General Corp.	GFF	Class I	1995-03-01
K950391	Non-Prescription Sunglasses	Aceway Sunglasses Corp.	HQY	Class I	1995-03-01
K950307	Biostrip(r) Hcg-One Step Pregnancy Test	Princeton BioMeditech Corp.	DHA	Class II	1995-03-01
K950226	Children's Sunglasses	Consolidated Stores Corp.	HQY	Class I	1995-03-01
K950132	Dumex Wet Dressings	Dumex Medical Surgical Products, Ltd.	FRO	Unclassified	1995-03-01
K950091	Konan Noncon Robo Specular Microscope, Models Sp 6000 and Sp 8000	Konan Medical, Inc.	HKI	Class II	1995-03-01
K946355	Dma Albumin Procedure	Data Medical Associates, Inc.	CIX	Class II	1995-03-01
K946187	Spirit II and Spirit Treatment Center	KaVo Dental Technologies, LLC	EIA	Class I	1995-03-01
K946129	Implant Body Depth Gauge/tryin	O Co., Inc.	DZE	Class II	1995-03-01
K946115	Ek-View(tm) ECG Management System	Apcot Medical Systems	DXG	Class II	1995-03-01
K946113	Implant Body Retriever/remover	O Co., Inc.	DZE	Class II	1995-03-01
K945959	Video Vision Analyzer (Viva), Vrb 100	Tomey Corporation USA	HKO	Class I	1995-03-01
K945861	Bergen 710 Esu	Bergen Mfg.	HAM	Class II	1995-03-01
K945832	Brady Medical Products Transcorbent and Thinsite Topical Border Wound Dressings	Brady Medical Products Co.	NAE	Class I	1995-03-01
K945715	Monoject(r) Piston Syringes; 3,6,12,20,35 and 60Cc Sizes	Sherwood Medical Co.	FMF	Class II	1995-03-01
K944048	Ultrasound 77030 Imaging System	Hewlett-Packard Co.	IYN	Class II	1995-03-01
K943984	Kis-II Non-Angulated Abutments	Implant Center of the Palm Beaches	DZE	Class II	1995-03-01