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 813 of 3530

510(k) clearances, page 813 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K131207	Femto Ldv(tm) Z-Generation Femtosecond Surgical Laser	Surgical Instrument Engineering AG	HQF	Class II	2013-10-09
K130390	Comprehensive Convertible Glenoid	Biomet Manufacturing Corp	PHX	Class II	2013-10-09
K130379	Rollins 7 Oxygen Mask	Rollins Medical Solutions, Inc.	CAF	Class II	2013-10-09
K123205	Esophageal Tts Stent	Taewoong Medical Co., Ltd.	ESW	Class II	2013-10-09
K132829	Quadrox-I, Quadrox-Id, Quadrox-Ir Oxygenators	MAQUET CARDIOPULMONARY GmbH	DTZ	Class II	2013-10-08
K132734	Neutral Luer Activated Device (One-Link Needle-Free IV Connector) and Extension Sets	Baxter Healthcare Corporation	FPA	Class II	2013-10-08
K132589	Anterior Lumbar Plate System (Presidio)	Life Spine	KWQ	Class II	2013-10-08
K132471	Cd Horizon Spinal System	Medtronic Sofamor Danek USA Inc	NKB	Class II	2013-10-08
K132362	Weck Efx Endo Fascial Closure System	Teleflexmedical, Inc.	OCW	Class II	2013-10-08
K132224	Unimed Surgical Coated Electrosurgical Electrodes	Unimed Surgical Products, Inc.	GEI	Class II	2013-10-08
K132142	Neria Soft 90 Infusion Set	Unomedical A/S	FPA	Class II	2013-10-08
K131585	Intel-Ge Care Innovations Quietcare	Intel-Ge Care Innovations, LLC	KMI	Class I	2013-10-08
K131472	Apex Knee Modular Tibia System	Omni Life Science, Inc.	JWH	Class II	2013-10-08
K131362	Inmode Wmbody Device	Inmode MD, Ltd.	NUV	Class II	2013-10-08
K131353	Comprehensive Reverse Shoulder - Titanium Glenosphere	Biomet Manufacturing Corp	PHX	Class II	2013-10-08
K131186	Synthes 2.7Mm and 3.5Mm Variable Angle Lcp Midfoot/hindfoot System	Synthes (USA) Products LLC	HRS	Class II	2013-10-08
K131015	Biodesign Onlay Dural Graft or Biodesign Duraplasty Graft	Cook Biotech, Inc.	GXQ	Class II	2013-10-08
K130857	Prontosan Wound Gel X	B.Braun Medical, Inc.	FRO	Unclassified	2013-10-08
K130834	R7	Cefla S.C.	ELC	Class II	2013-10-08
K130110	Meddusa Bipolar System	Elliquence LLC	GEI	Class II	2013-10-08
K133017	Estech Cobra(r) Genesis Bipolar Clamp	Estech, Inc.	GEI	Class II	2013-10-07
K132337	Esoflip Balloon Dilation Catheter	Crospon, Ltd.	PID	Class II	2013-10-07
K131771	Caregiver Professional Clinical Thermometer, Pro-Tf Series	Thermomedics, Inc.	FLL	Class II	2013-10-07
K131769	Cinchlock Knotless Suture Anchor, Nanotack Suture Anchor 1.4Mm	Pivot Medical	MBI	Class II	2013-10-07
K131749	Hem-6221	Omron Healthcare Co., Ltd.	DXN	Class II	2013-10-07
K131645	Instant-View Multi-Drug of Abuse Urine Test (Cup, Panel Cassette)	Alfa Scientific Designs, Inc.	DKZ	Class II	2013-10-07
K131483	Philips Pixium 4343Rc	Philips Medical Systems DMC GmbH	MQB	Class II	2013-10-07
K131479	V8 Sp Normal Control, Abnormal Control	Helena Laboratories, Corp.	JJY	Class I	2013-10-07
K131201	Entuit Secure Gastrointestional Suture Anchor Set, Entuit Secure Adjustable Gastrointestinal Suture Anchor Set	Cook Inc.	FGE	Class II	2013-10-07
K131143	Trellis Collagen Ribbon	Wrightmedicaltechnologyinc	OWY	Class II	2013-10-07
K130940	Kymco Eq20c Scooter	Kwang Yang Motor Co., Ltd.	INI	Class II	2013-10-07
K130709	Visi Mobile Monitoring System	Sotera Wireless	MWI	Class II	2013-10-07
K132905	200 Micron Blood Component Filter and Syringe Adapter	Arteriocyte Medical Systems, Inc.	BRZ	Class II	2013-10-04
K132863	Smartsite Vialshield	Yukon Medical, LLC	LHI	Class II	2013-10-04
K132861	Ugeo H60 Diagnostic Ultrasound System	Samsung Medison Co., Ltd.	IYN	Class II	2013-10-04
K132768	S8 Exp Portable Digital Color Doppler Ultrasound System	Sonoscape Company Limited	IYN	Class II	2013-10-04
K132719	Staxx Ibl System	Spine Wave Inc	MAX	Class II	2013-10-04
K132645	Thoratrak Mics Retractor System, Rack, Blades	Medtronic, Inc.	GAD	Class I	2013-10-04
K132454	Vitaheat Patient Warming System	Vitaheat Medical, LLC	DWJ	Class II	2013-10-04
K132440	Xpress Multi-Sinus Dilation Tool	Entellus Medical, Inc.	LRC	Class I	2013-10-04
K131948	Microplex Coil System (Mcs)	Terumo Cardiovascular Systems Corporation	HCG	Class II	2013-10-04
K131820	Avamax Vertebral Balloon System, 8G, Avamax Vertebral Balloon System, 10G, Avamax Vertebral Balloon System, 11G	Care Fusion	HRX	Class II	2013-10-04
K131709	Sinus Dilation System with Cannulated Instrument	ArthroCare Corporation	LRC	Class I	2013-10-04
K130628	Pathfast Ck-Mb-II Calibrators	Mitsubishi Chemical Medience Corporation	JIT	Class II	2013-10-04
K122800	Inner Peace	Kamabry, Inc., dba Inner Peace for Women	HIR	Class II	2013-10-04
K121447	Ischema View Rapid	Ischemaview, Inc.	LLZ	Class II	2013-10-04
K132774	Piccolo Composite Nailing System	CarboFix Orthopedics Inc.	HSB	Class II	2013-10-03
K132760	Nautilus Spinal System	Life Spine	NKB	Class II	2013-10-03
K132675	Embozene Microspheres	Celonova Biosciences, Inc.	KRD	Class II	2013-10-03
K132642	Locking Plate System	Beijing Libeier Bio-Engineering Institute Co., Ltd.	HRS	Class II	2013-10-03