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 1913 of 3531

510(k) clearances, page 1913 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K963051	Ercp Cannula	United States Endoscopy Group, Inc.	ODD	Class II	1997-03-28
K962687	Gio. De Vita E C. S.r.l.(gdv) Automatic Washing System	Nichols Institute Diagnostics	JQW	Class I	1997-03-28
K961782	Bio-Binki	Biomni Medical Systems, Inc.	JAA	Class II	1997-03-28
K961676	Aircast Venaflow System (Modification)	Aircast, Inc.	JOW	Class II	1997-03-28
K960840	C.e. Vascular Machine	C.E. Diagnosis, Inc.	JEH	Class II	1997-03-28
K955721	Cuffed Oropharyngeal Airway (Copa)	Mallinckrodt Medical	CAE	Class I	1997-03-28
K951944	Nasalflair	Airways Ltd., Inc.	BZD	Class II	1997-03-28
K970815	Convertors Impervious Shoe Covers	Medtronic, Inc.	FXP	Class I	1997-03-27
K970788	Pneumo-Matic Insufflation Needle	CooperSurgical, Inc.	FHO	Class II	1997-03-27
K970625	Poly-Med	Shinemound Enterprise, Inc.	LYY	Class I	1997-03-27
K970440	Ekonic Dental/medical Mask (Md 610)	Ekonic Company, Ltd.	FXX	Class II	1997-03-27
K970433	Aquasil Rigid Smart Wetting Impression Material	Dentsply Intl.	ELW	Class II	1997-03-27
K970111	Jiawang Powder-Free Vinyl Examination Gloves	Shanghai Jiawang Industrial Co., Ltd.	LYZ	Class I	1997-03-27
K970076	Nipro Disposable Solution Infusion Set	Nipro Medical Corporation	FPA	Class II	1997-03-27
K965091	Teethmate F-1	Kuraray Co.	EBC	Class II	1997-03-27
K964387	Point of Use II Sharps-a-Gator	Graphic Controls Corp.	MMK	Class II	1997-03-27
K964021	Intramed Side Branch Occlusion (Sbo) System (700095 and 700099)	Baxter Edwards	HCG	Class II	1997-03-27
K970904	Widex Senso Digital (Cic)	Widex Hearing Aid Co., Inc.	ESD	Class I	1997-03-26
K970402	Doctors Review System	Digisonics, Inc	LLZ	Class II	1997-03-26
K970340	Air Conduction Assistive Listening Device.personal Amplifier	Bellab	LZI	Class II	1997-03-26
K965131	Borrelia Burgdorferi Igg/igm Elisa Test System	Wampole Laboratories	LSR	Class II	1997-03-26
K965129	Borrelia Burgdorferi Igm Elisa Test System	Wampole Laboratories	LSR	Class II	1997-03-26
K964915	Magnesium	Derma Media Lab., Inc.	JGJ	Class I	1997-03-26
K964891	Orbshot Keratometer	Orbtek, Inc.	MMQ	Class I	1997-03-26
K964404	Bacfix Spinal Fixation System	Spinal Concepts, Inc.	KWP	Class II	1997-03-26
K964024	Depuy Motech Titanium Moss Miami Spinal System	Depuy, Inc.	KWP	Class II	1997-03-26
K963775	Model 8800 Aspirator	Medical Specifics, Inc.	BTA	Class II	1997-03-26
K961459	Level 10 Hdi	Advanced Technology Laboratories, Inc.	IYO	Class II	1997-03-26
K960849	Magno Alarm	Cardiac Assist Devices, Inc.	DTG	Class I	1997-03-26
K970994	Core and Coil Assembly Guidewire	Lake Region Mfg., Inc.	EZB	Class I	1997-03-25
K970538	Victory Eyewear Co	Victory Eyewear Co., Ltd.	HQY	Class I	1997-03-25
K970356	Irrigation/aspiration Polypectomy	United States Endoscopy Group, Inc.	FDI	Class II	1997-03-25
K970161	Hedges Corneal Wetting Pak	Hedges Cwp, Inc.	KYG	Class I	1997-03-25
K970089	Innovasive 2.8Mm and 3.5Mm Roc Lf Suture Bone Fastener	Innovasive Devices, Inc.	MBI	Class II	1997-03-25
K970052	Extractorrx	Boston Scientific Corporation	FGE	Class II	1997-03-25
K970036	Fixation Pin or Rod	United States Surgical, A Division of Tyco Healthc	HTY	Class II	1997-03-25
K970019	Menicon Z Bifocal Design Lens/menicon Z Trifocal Design Lens	Menicon U.S.A., Inc.	LPL	Class II	1997-03-25
K965019	The C-Fit Femoral Hip System	Corin USA	JDI	Class II	1997-03-25
K964359	Avanta Orthopaedics Tendon Spacer	Avanta Orthopaedics, Inc.	HXA	Class II	1997-03-25
K963325	Synthes Titanium (Ti) Alloy High Tibial Osteotomy (Hto) System	Synthes (USA) Products LLC	HRS	Class II	1997-03-25
K963203	Bentley Quick-Prime Hemoconcentrator with Duraflo Treatment	Baxter Healthcare Corporation	KDI	Class II	1997-03-25
K962970	Spacelabs Medical 12-Lead Diagnostic ECG Analysis Option	GE Healthcare	DSI	Class II	1997-03-25
K970597	Culture-Pak Collection and Transport System with Clinical Transport Media (Cary-Blair Option)	Medical Packaging Corporation	JSM	Class I	1997-03-24
K970539	Chiron Diagnostics Acs:180tu P	Chiron Diagnostics Corp.	KHQ	Class II	1997-03-24
K970120	Bile Acids Reagent Set	Teco Diagnostics	KWW	Class II	1997-03-24
K970068	Jelenko No.1 (Code Name Rd-0601)	J.F. Jelenko & Co., Inc.	EJT	Class II	1997-03-24
K965189	Spinnaker	Target Therapeutics	KRA	Class II	1997-03-24
K965186	Axsym B12	Abbott Medical	CDD	Class II	1997-03-24
K964844	Conmed: Stat 2 and Stat 2 Pumpette Extension Sets and Masterflow and Masterflow Pumpette Primary Sets	Conmedcorp	FPA	Class II	1997-03-24
K964841	Elecsys Progesterone Assay	Boehringer Mannheim Corp.	JLS	Class I	1997-03-24