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 1563 of 3531

510(k) clearances, page 1563 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K013466	Spife 2000/3000 Lipoprotein; Model# 3340, 3341, 3342, 3343	Helena Laboratories, Corp.	JHO	Class I	2001-12-21
K013436	Normatec Pcd	Normatec, Inc.	JOW	Class II	2001-12-21
K013371	Ubit-Ir300 Infrared Spectrometry System	Otsuka Pharmaceutical Co., Ltd.	JJQ	Class I	2001-12-21
K013193	Mega Beam/ceralas Nonsterile Collimating Handpiece	Biolitec, Inc.	GEX	Class II	2001-12-21
K013056	Gelclair Concentrated Oral Gel	Sinclair Pharmaceuticals Ltd	OLR	Unclassified	2001-12-21
K012569	Modification to: Injectable Mimix	Zimmer GmbH	GXP	Class II	2001-12-21
K012514	Digipan / Dpi	Trophy Radiologie	MUH	Class II	2001-12-21
K011960	Lares Research Sunlase 800P Laser System (to Be Sold as Pocketpro or Pocketpro S4)	Lares Research	GEX	Class II	2001-12-21
K011953	Wiener Lab. Glicemia Enzimatica Aa Models 1 X 250 Ml Cat. #1400106; 4 250 Ml Cat. # 1400107; Wiener Lab. Gilicemia Enzca	Wiener Laboratories Saic	CGA	Class II	2001-12-21
K011889	Ultra -Thin Sds Balloon Dilatation Catheter	Boston Scientific Corporation	DQY	Class II	2001-12-21
K011832	Vanguard Reprocessed Femoral Compression Device	Stryker Sustainability Solutions	NMF	Class II	2001-12-21
K011702	Vertis Pnt Control Unit, Vertis Pnt Safeguide Kids, Models Cu100, Sgxxx	Vertis Neuroscience, Inc.	NHI	Class II	2001-12-21
K014116	Hand-Carried Ultrasound System	FUJIFILM SonoSite,Inc.	IYN	Class II	2001-12-20
K013916	Melker Emergency Cricothyrotomy Catheter Set	Cook Inc.	BWC	Class II	2001-12-20
K013901	Malleable Surgical Lightstic 180, Model 180 (1Cm-9Cm)	CardioFocus, Inc.	GEX	Class II	2001-12-20
K013512	Aosept Clear Care Cleaning and Disinfecting Solution	Alcon Laboratories	LPN	Class II	2001-12-20
K013475	Trident Porous Titanium Acetabular Component with Peri-Apatite Coating	Howmedica Osteonics Corp	LPH	Class II	2001-12-20
K013446	Glusite, Model Glu002	Glustitch, Inc.	EMA	Class II	2001-12-20
K013438	Frialit-2 Estheticbase Abutment	Friadent GmbH	DZE	Class II	2001-12-20
K013424	Intramedullary Fixation System for the Hand	Hand Innovations, Inc.	HTY	Class II	2001-12-20
K013419	Nicolet Electromagnetic Navigation System	Nicolet Biomedical, Inc.	LLZ	Class II	2001-12-20
K013377	Biomedics UV Colors (Ocufilcon D) Soft (Hydrophilic) Contact Lens	Ocular Sciences Puerto Rico, Inc.	LPL	Class II	2001-12-20
K013340	Rt-Plus Knee Additional Components	Plus Orthopedics	KRO	Class II	2001-12-20
K013308	Ventlab Hyperinflation Bag System	Salter Labs	NHK	Class II	2001-12-20
K013273	Fukuda Denshi Model Hg-500, Pulse Oximeter Module	Fukuda Denshi USA, Inc.	DQA	Class II	2001-12-20
K013226	Evenflo Comfort Ease Manual Breast Pump Kit	Evenflo Company, Inc.	HGY	Class I	2001-12-20
K013218	Fuji Speed Suite, Fuji Speed Sute Phase II	FUJIFILM Healthcare Americas Corporation	MQB	Class II	2001-12-20
K013172	Porges Silicone Prostatectomy Catheter, Straight Cylindrical Tip, Delinotte Tip, Dufour Tip, Over the Guide Tip, Model	Porges Corp.	EZL	Class II	2001-12-20
K013132	Sign Im Nail	Surgical Implant Generation Network (Sign)	HSB	Class II	2001-12-20
K012660	Gimmi'alpha' Endoscopes & Accessories	Gimmi GmbH	FET	Class II	2001-12-20
K012327	Csist Dicom Gateway/image Manager	Csist	LLZ	Class II	2001-12-20
K012323	BIPAP Synchrony Ventilatory Support System	Respironics, Inc.	MNS	Class II	2001-12-20
K012256	Gelbish Vascular Dilator	Vascumetrix, LLC	DRE	Class II	2001-12-20
K011897	Norian Srs Bone Void Filler	Synthes (USA) Products LLC	MQV	Class II	2001-12-20
K011255	3D Line Sterotactic Hardware Accessories	3D Line USA, Inc.	HAW	Class II	2001-12-20
K011212	Filterflo H	Arc Medical, Inc.	CAH	Class II	2001-12-20
K011139	Lorenz Lactosorb Panels and Fasteners	Zimmer GmbH	HRS	Class II	2001-12-20
K010793	Oxylog 1000, Model 2M86840	Drager Medizintechnik GmbH	CBK	Class II	2001-12-20
K010559	Sauflon Multi Lens Care System	Sauflon Pharmaceuticals, Ltd.	LPN	Class II	2001-12-20
K993836	Generation 4 Bone Cement	Zimmer GmbH	LOD	Class II	2001-12-19
K013989	Zirconia Ceramic Femoral Head - 12/14 Taper	Smith & Nephew, Inc.	LZO	Class II	2001-12-19
K013877	Codman Slim-Loc System	Cerenovus, Inc.	KWQ	Class II	2001-12-19
K013860	Auto Suture Surgical Staples	United States Surgical, A Division of Tyco Healthc	GDW	Class II	2001-12-19
K013829	Modification to Townley Transfacetpedicular Screw Fixation System	Medtronic Sofamor Danek	MRW	Unclassified	2001-12-19
K013823	Xia Spinal System	Howmedica Osteonics Corp	KWP	Class II	2001-12-19
K013798	Prosthetic Accessories to the Iti Dental Implant System	Straumann USA, LLC	DZE	Class II	2001-12-19
K013616	Polarus Cap Screw	Acu Med, Inc.	HSB	Class II	2001-12-19
K013553	Pre-Loaded Ultrafix Rc	Linvatec Corporation	MBI	Class II	2001-12-19
K013505	Aurofluid Plus	Metalor Technologies USA	EJT	Class II	2001-12-19
K013449	Modification to Fixion Interlocking Intramedullary Nailing System	Disc-O-Tech Medical Technologies, Ltd.	HSB	Class II	2001-12-19