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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 832 of 3530

510(k) clearances, page 832 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K123087	Tysonbio Ac500, Ac800 Blood Glucose Monitoring System, Tysonbio Ac500 Ac800 Pro Blood Glucose Monitoring System	Tyson Bioresearch, Inc.	NBW	Class II	2013-06-18
K123016	Veri-Q Self-Testing and Veri-Q Plus Mgd-2001 Blood Glucose Monitoring Systems	Mico Biomed Co., Ltd.	NBW	Class II	2013-06-18
K122820	Viky Up	Endocontrol	LKF	Class II	2013-06-18
K130577	Azur Pushable 18 & 35 System	Terumo Cardiovascular Systems Corporation	KRD	Class II	2013-06-17
K130309	Rapidflap Ls Cranial Flap Fixation System	Biomet Microfixation	GXR	Class II	2013-06-17
K123793	Sofia Strep a Fia	Ortho-Clinical Diagnostics, Inc.	GTY	Class I	2013-06-17
K123590	Vinyl Examination Powder Free Gloves, Clear	Weilin Plastic and Rubber Products Co., Ltd.	LYZ	Class I	2013-06-17
K123431	Dream Color I (Polymacon) Soft (Hydrophilic) Contact Lens, Dream Color II (Polymacon) Soft (Hydrophilic) Contact Lens, D	DreamCon Co. Ltd.	LPL	Class II	2013-06-17
K122809	Advin Multi-Drug Screen Test Cassette, Dip Card and Cup	Advin Biotech, Inc.	DKZ	Class II	2013-06-17
K122715	Stellar 150	Resmed Germany, Inc.	MNT	Class II	2013-06-17
K130414	Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta Balloon Catheter (Over the Wire) 0.018	Trireme Medical, Inc.	LIT	Class II	2013-06-15
K131569	Pg-800A Series	Shenzhen Pango Electronic Co., Ltd.	DXN	Class II	2013-06-14
K131291	Torc Body	Johari Digital Healthcare, Ltd.	NGX	Class II	2013-06-14
K130995	Nuance Cryo-Freeze Spray or Cryo-in-a-Can or Vandolay Freeze Spray	Nuance Medical, LLC	GEH	Class II	2013-06-14
K130992	Pinnacle3 Radiation Therapy Planning System	Philips North America LLC	IYE	Class II	2013-06-14
K130912	Omnicut Resection Blade	DePuy Mitek, Inc.	HRX	Class II	2013-06-14
K130902	Emory Cardiac Toolbox 3.2	Syntermed, Inc.	KPS	Class II	2013-06-14
K130867	Enflow IV Fluid Warmer Insulated Strap	Vital Signs, Inc., A GE Healthcare Company	LGZ	Class II	2013-06-14
K130849	Intellivue Patient Monitor Mx400; Intellivue Patient Monitor Mx450	Philips Medizinsysteme Boeblingen GmbH, Cardiac an	MHX	Class II	2013-06-14
K130801	Digital Color Doppler Ultrasound System	Sonoscape Company Limited	IYN	Class II	2013-06-14
K130542	Synapse 3D Lung and Abdomen Analysis	FUJIFILM Healthcare Americas Corporation	LLZ	Class II	2013-06-14
K130443	I-Max Touch 3D	Owandy Inc.	OAS	Class II	2013-06-14
K130193	Fraxel Dual 1550/1927 Laser System	Solta Medical, Inc.	GEX	Class II	2013-06-14
K124018	Amia Automated Pd System	Deka Research & Development Corp.	FKX	Class II	2013-06-14
K123810	Piccolo Composite Ankle Arthrodesis Nailing System	CarboFix Orthopedics Inc.	HSB	Class II	2013-06-14
K123127	Validate Psa Calibration Verification/ Linearity Test Kit Model 406	Maine Standards Co.	JJX	Class I	2013-06-14
K122950	Laser Helmet	Theradome, Inc.	OAP	Class II	2013-06-14
K122551	Provitemp	Itena Clinical	EMA	Class II	2013-06-14
K121618	Bel-Gen Cold Storage Solution	Waters Medical Systems LLC	KDL	Class II	2013-06-14
K121343	Modulap Loop	Atc Technologies Inc.	KNF	Class II	2013-06-14
K121284	Chabner Xrt Garments	Chabner XRT, LLC	IYE	Class II	2013-06-14
K121214	Access Accutni+3 Reagent and Access Accutn1+3 Calibrators for Use on the Access 2 Immunoassay System	Siemens Healthcare Diagnostics Inc.	MMI	Class II	2013-06-14
K131237	Pipeline Total Hip System	Pipeline Orthopedics	LPH	Class II	2013-06-13
K130787	Quantum Dental Implant System	Quantum Bioengineering, Ltd.	DZE	Class II	2013-06-13
K130753	Standard Contact Lens Case; Flip N Slide Contact Lens Case	Watchdog Group, LC	LRX	Class II	2013-06-13
K130630	Plateau Spacer System Titanium	Life Spine	MAX	Class II	2013-06-13
K130380	Orthosensor Knee Balancer	Orthosensor, Inc.	ONN	Class II	2013-06-13
K130104	Guidewire, Pursuer Series	Oscor Inc.	DQX	Class II	2013-06-13
K130015	Shaser V-Mini Hair Removal System	Shaser, Inc.	ONF	Class II	2013-06-13
K122449	Enteral Nutrition Warmer	Acacia, Inc.	LGZ	Class II	2013-06-13
K130690	Z-800 Infusion System	Zyno Medical LLC.	FRN	Class II	2013-06-12
K130642	Smr 3-Pegs Glenoids	Lima Corporate S.p.A.	KWS	Class II	2013-06-12
K130416	Nexus Tko-6P Luer Activated Device	Nexus Medical, LLC	FPA	Class II	2013-06-12
K130191	Mint	Hans Biomed Corp.	NEW	Class II	2013-06-12
K123261	Euroimmun Anti-Nrnp/sm Elisa (Igg)	Euroimmun US Inc.	LKO	Class II	2013-06-12
K122973	Al-106, Al-106Sa and Al-106B Medgyn Digital Video Colposcope	Medgyn Products, Inc.	HEX	Class II	2013-06-12
K122588	Vusion Cs Plus	Ortho Development Corp.	ODP	Class II	2013-06-12
K131528	Non-Pyrogenic Ultrasound Transducer Cover	CIVCO Medical Instruments Co., Inc.	ITX	Class II	2013-06-11
K131303	Disposable Circular Stapler	Changzhou City Zhiye Medical Devices Institute Co.	GDW	Class II	2013-06-11
K130567	Dr Long Length Imaging Software	Eastman Kodak Company	MQB	Class II	2013-06-11