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 2192 of 3531

510(k) clearances, page 2192 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K926594	Owens Laparoscopy Instruments and Accessories	Owens Industries, Inc.	HET	Class II	1994-06-06
K942375	Sunglasses	Kool World, Inc.	HQY	Class I	1994-06-03
K942238	i.v. Startpak Vascular Access Start Kit	BD Becton Dickinson Vacutainer Systems Preanalytic	LRS	Class II	1994-06-03
K942034	R&d Batteries, Part Nos. 5135, 5097, 5444, and 5502	R & D Batteries, Inc.	HLJ	Class II	1994-06-03
K941875	Sunglasses	The Limited Stores, Inc.	HQY	Class I	1994-06-03
K941873	Sunglasses	Koadak Optical Industrial Co., Ltd.	HQY	Class I	1994-06-03
K941767	Frames - Various Brand Names	Lenscraft, Inc.	HQZ	Class I	1994-06-03
K941751	Sunglasses	The Orvis Co., Inc.	HQY	Class I	1994-06-03
K941649	Surgical Sponge	Industries for the Blind & Visually Impaired	EFQ	Unclassified	1994-06-03
K941602	Spectacle Frames	Slim Occhiali	HQZ	Class I	1994-06-03
K941576	Spectacle Frames/sunglasses	Sanders Optical Co., Inc.	HQY	Class I	1994-06-03
K941394	Stat Fax 2600	Awareness Technology, Inc.	JQW	Class I	1994-06-03
K941296	Sunglasses	Three Leaves Industrial Co., Ltd.	HQY	Class I	1994-06-03
K941220	Dupont Aca Plus Prolactin (Prol) Method	Dupont Medical Products	CFT	Class I	1994-06-03
K941130	Assure Urine Hcg Control	Quantimetrix Corp.	JJX	Class I	1994-06-03
K940947	Crown,ski Optic Sunglasses	Sunglass Experts	HQY	Class I	1994-06-03
K940874	Model 900Ge1500 Head/neck Coil	Medic, Inc.	LNH	Class II	1994-06-03
K940850	Sunglasses (Non-Prescription)	Fantasia Novelty Ent. Corp.	HQY	Class I	1994-06-03
K940831	Ski Vector Non-Prescription Sunglasses	Mountain Shades, Inc.	HQY	Class I	1994-06-03
K940741	Mountain Shades -Nonprescription Sunglasses	Mountain Shades, Inc.	HQY	Class I	1994-06-03
K940740	Ski Vector Non Precription Sunglasses	Mountain Shades, Inc.	HQY	Class I	1994-06-03
K940737	Edta Gel (Tm)	Karolinska Institutet	EBF	Class II	1994-06-03
K940090	Arthroscope	Richard Wolf Medical Instruments Corp.	HRX	Class II	1994-06-03
K940035	Kit,i.v. Start	Mason-Keller Corp.	LYZ	Class I	1994-06-03
K936043	Foundation Porous Acetabular Component	Encore Orthopedics, Inc.	JDI	Class II	1994-06-03
K935843	Be-Safe	Mathis-Koolpe, Inc.	FMI	Class II	1994-06-03
K935262	P.f.c. Total Knee System Oval Patella	Johnson & Johnson Orthopaedics, Inc.	JWH	Class II	1994-06-03
K934860	Ti-Frame	Johnson & Johnson Professionals, Inc.	KWP	Class II	1994-06-03
K934576	Sunglasses	Guide Firm, Ltd.	HQY	Class I	1994-06-03
K934412	Coated Zt Proximal Sleeve	Joint Medical Products Corp.	LPH	Class II	1994-06-03
K934354	Lacey All Polyethylene Tibial Component	Dow Corning Wright	JWH	Class II	1994-06-03
K932669	Supra-Vit(tm)	Medical Instrument Development Laboratories, Inc.	HQE	Class II	1994-06-03
K932598	Tn-Rd-50	Keithley Instruments, Inc.	IYE	Class II	1994-06-03
K926209	Eub-555	Hitachi Medical Corp.	IYO	Class II	1994-06-03
K942314	Lorrex Gauze Sponges Specialty	Lorrex Health Products	EFQ	Unclassified	1994-06-02
K942274	Orion Suction Catheter Kit with Sterile Saline	Regulatory & Marketing Services, Inc.	GBX	Class I	1994-06-02
K942273	Orion Suction Catheter Kit with Sterile Water	Regulatory & Marketing Services, Inc.	GBX	Class I	1994-06-02
K942199	Cu-100R Light Cure Unit, Document No. A715676	Rolence Enterprise Co., Ltd.	EBZ	Class II	1994-06-02
K941310	Cedia Dau Cocaine Assay	Microgenics Corporation	DIO	Class II	1994-06-02
K941305	Wilson-Cook Variable Length Gi Injection Needle	Wilson-Cook Medical Inc.	FBK	Class II	1994-06-02
K941175	Access Prolactin	Bio-Rad Laboratories Inc.	CFT	Class I	1994-06-02
K941090	Unistep Hcg Pregnancy Test Strip	Biotech Atlantic, Inc.	DHA	Class II	1994-06-02
K940972	Model Mcc - Mkiv Micro Computer Controls	Invacare GmbH	ITI	Class II	1994-06-02
K940955	Reflex Egr	Ricard-Allan Medical	GEI	Class II	1994-06-02
K940912	Usdt Cannabinoid (Thc) Assay Column Catalog No. 9000-500	U.S. Drug Testing, Inc.	LDJ	Class II	1994-06-02
K940816	Bard(r) Expanded PTFE Vascular Graft	C.R. Bard Inc	DSY	Class II	1994-06-02
K940637	Predictor Home Pregnancy Test	bioMerieux, Inc.	LCX	Class II	1994-06-02
K940461	Alexantriptor	Servicetrends, Inc.	GEX	Class II	1994-06-02
K940457	Lipase Reagent System	Medical Diagnostic Technologies, Inc.	CET	Class I	1994-06-02
K940385	Navigator-Mp Catheter Location Instrument	Navion Biomedical Corp.	FOZ	Class II	1994-06-02