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 1277 of 3531

510(k) clearances, page 1277 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K060032	Rt300-S, Model Fa100052; Rt300-Sp, Model Fa100053	Restorative Therapies Inc.	GZI	Class II	2006-03-10
K053511	Da Vinci Femtosecond Surgical Laser	Sie Ltd Surgical Instrument Engineering	GEX	Class II	2006-03-10
K053398	Compass Compression Assist Handle	Semler Technologies, Inc. dba	DXC	Class II	2006-03-10
K053335	Premier Platinum Hpsa Plus, Models 601396, 601480	Meridian Bioscience Inc	LYR	Class I	2006-03-10
K053284	Magbody Dt-600	Durtech System Corp.	GZJ	Class II	2006-03-10
K053102	Biogel Skinsense Powder-Free Non-Latex Surgeon's Glove	Regent Medical Americas, LLC	KGO	Class I	2006-03-10
K052839	CT Perfusion 4	GE Healthcare	JAK	Class II	2006-03-10
K052212	Migue	Direx Systems Corp.	IYE	Class II	2006-03-10
K051477	Migwang Comfort 38 (Polymacon) Spherical and Toric Soft Contact Lens for Daily Wear (Clear, Tinted and Cosmetic)	MI Gwang Contact Lens Co., Ltd.	LPL	Class II	2006-03-10
K051128	Electropulse	Pain Relief Technologies	GZJ	Class II	2006-03-10
K060481	Liberty Glucose Control Solution	Liberty Healthcare Group, Inc.	JJX	Class I	2006-03-09
K060453	Aze Virtualplace	Aze, Ltd.	LLZ	Class II	2006-03-09
K060426	Liberty Glucose Normal Control Solutions, Model 2120041	Liberty Healthcare Group, Inc.	JJX	Class I	2006-03-09
K060422	Lysus Infusion System	Ekos Corp.	QEY	Class II	2006-03-09
K060378	Vitrea2 Version 3.8.1	Canon Medical Informatics, Inc.	LLZ	Class II	2006-03-09
K060371	The Emit 2000 Tacrolimus Calibrators	Siemens Healthcare Diagnostics Inc.	JIT	Class II	2006-03-09
K060338	Family of Selecta Laser Systems Including Selecta 1064, Selecta Slt, Selecta Duet, Selecta Duo, Selecta Trio	Lumenis Ltd	GEX	Class II	2006-03-09
K060266	Dimension Iron Calibrator	Siemens Healthcare Diagnostics Inc.	JIS	Class II	2006-03-09
K060214	Bd Phoenix Automated Mircrobiology System Tetracycline-Gn 0.5-16 Ug/ml and Gp 0.5-16 Ug/ml	Becton Dickinson & Co	LON	Class II	2006-03-09
K060092	Quickcat Extraction Catheter	DSM Biomedical, Inc.	QEZ	Class II	2006-03-09
K060035	Mdxnet	Cybermdx, Inc.	LLZ	Class II	2006-03-09
K060023	Angiodynamics Total Abscession Biliary Drainage Catheter	Boston Scientific Corporation	FGE	Class II	2006-03-09
K053645	Modification To:bair Hugger Temperature Management Systems	Arizant Healthcare, Inc.	DWJ	Class II	2006-03-09
K053553	Nycocard U-Albumin and U-Albumin Control	Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, LLC	DCF	Class II	2006-03-09
K053488	Conformis Bicompartmental Knee Repair System	ConforMIS, Inc.	NPJ	Class II	2006-03-09
K053485	Theratron Equinox, Models 80 Cm and 100 Cm	Mds Nordion	IWB	Class II	2006-03-09
K053280	Probeat	Hitachi, Ltd., Power Systems Group	LHN	Class II	2006-03-09
K053194	Noga Xp Cardiac Navigation System with Qwikmap Software	Biosense Webster Inc	DQK	Class II	2006-03-09
K052207	Accurex Glucose Test Strip	Incline Medical, LLC	CGA	Class II	2006-03-09
K051839	Free-Style Freedom Blood Glucose Monitoring System, Model 11001	Abbott Medical	NBW	Class II	2006-03-09
K060337	Belimed Steam Sterilizer Top 5000, Model 5-5-9	Sauter AG	FLE	Class II	2006-03-08
K060264	Dimension Iron Flex Reagent Cartridge (Iron-Df85)	Siemens Healthcare Diagnostics Inc.	JIY	Class I	2006-03-08
K060251	Wh Convertible Lightweght Wheelchair, Model Whl100	Well Home Health Products Co.	IOR	Class I	2006-03-08
K060146	Activecare ++ System	Medical Compression Systems (Dbn), Ltd.	JOW	Class II	2006-03-08
K060077	Rtt Digital Wrist Blood Pressure Monitor, Model Rtw-8010A	Real Tone Technology Corp.	DXN	Class II	2006-03-08
K060068	Avanticare, Model Sa4021	Lerado China Limited	INI	Class II	2006-03-08
K060057	Protege Everflex Self-Expanding Biliary Stent System	Medtronic, Inc.	FGE	Class II	2006-03-08
K053573	Gss Pedicle Screw System	GS Medical Co., Ltd.	MNH	Class II	2006-03-08
K053251	Techdevice Guidewire	Techdevice Corporation	DQX	Class II	2006-03-08
K053217	Cps Aim Inner Catheter, Models 410140, 410141, 410142, 410144, 410145, 410146, 410147, 410148	Abbott Medical	DQY	Class II	2006-03-08
K052989	Dp240 240 Hour Doppler Probe	Deltex Medical Limited	DPT	Class II	2006-03-08
K052637	Therox Infusion Catheter, Model Inca-1	Therox, Inc.	DQO	Class II	2006-03-08
K051047	Colloss E Bone Void Filler	Ossacur AG	MQV	Class II	2006-03-08
K050709	Resolve Hemoglobin Kit, Jb-2 Staining System, Models Fr-9120, Fr-9400, Fr-9360, Fr-9367	Wallac Oy	GKA	Class II	2006-03-08
K060428	Css Cannulated Screw System	TORNIER Inc.	HWC	Class II	2006-03-07
K060212	Merits Model E Series Lift Chairs	Merits Health Products, Inc.	INO	Class II	2006-03-07
K060181	Compe1 1 -Ply Surgical Gowns	Standard Textile Co., Inc.	FYA	Class II	2006-03-07
K060103	Albert Browne Ltd. Verify Steam Value Indicators	Sybron Dental Specialties, Inc.	JOJ	Class II	2006-03-07
K053463	Aim Accuracy in Marking System	Georgene Austria	ITX	Class II	2006-03-07
K053442	Biogel Skinsense Poly-Isoprene Powder-Free Non-Latex Glove	Regent Medical Americas, LLC	KGO	Class I	2006-03-07