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 1368 of 3531

510(k) clearances, page 1368 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K042226	Syntex Powder-Free Nitrile Examination Glove, Tested for Chemotherapy	Syntex Healthcare Products Co., Ltd.	LZA	Class I	2004-09-30
K042065	Wallflex Enternal Colonic Stent and Anchor Lock Delivery System	Boston Scientific Corporation	MQR	Class II	2004-09-30
K042062	Peripheral Vascular Sheath Tunneler Sterilization Cassette	Bard Peripheral Vascular Inc	KCT	Class II	2004-09-30
K042059	Shoulder Fixation System	Hand Innovations, Inc.	LXT	Class II	2004-09-30
K042056	Az Ultrasonic System	J. Morita USA, Inc.	ELC	Class II	2004-09-30
K041767	Coolcube Coolpen	Bruce J. Sand M.D.	GEX	Class II	2004-09-30
K041651	Stryker Leibinger Skeletal Anchoring System	Stryker Leibinger	DZE	Class II	2004-09-30
K041139	Erchonia Eml Laser	Erchonia Medical, Inc.	NHN	Class II	2004-09-30
K040630	Trabecular Metal Femoral Cone Augments, Model 03-125-Zzzz	Implex Corp.	JWH	Class II	2004-09-30
K042569	8600 Vital Signs Monitor	Criticare Systems, Inc.	MWI	Class II	2004-09-29
K042474	Arion	Wavelight Laser Technologie AG	GEX	Class II	2004-09-29
K042361	Digital Portable X-Ray Units, Model Sp-HF-4.0 D	Sedecal USA, Inc	IZL	Class II	2004-09-29
K042277	Selector Quantum Ultrasonic Aspirator System	Integra NeuroSciences	LFL	Unclassified	2004-09-29
K042033	Hoveround Power Wheelchair, Model Hd700	Hoveround Corp.	ITI	Class II	2004-09-29
K042015	Advia Chemistry Glucose Oxidase Assay and Advia Chemistry Glucose Hexokinase	Bayer Healthcare, Diagnostics Division	CGA	Class II	2004-09-29
K041866	Abbott Axsym Testosterone Microparticle Enzyme Immunoassay (Meia)	Axis-Shield Diagnostics, Ltd.	CDZ	Class I	2004-09-29
K041830	Magellan Ratio Dispenser Kit	Medtronic Perfusion Systems	FMF	Class II	2004-09-29
K041739	Edwards E360 Surgical Ablation Device	Edwards Lifesciences LLC	GEX	Class II	2004-09-29
K041435	The Stripper Pgd	Mid-Atlantic Diagnostics, Inc.	MQH	Class II	2004-09-29
K040658	Bardex I.c. Latex Foley Catheter	C.R. Bard Inc	MJC	Class II	2004-09-29
K031611	P4-Fitness	Valmed SRL	NGX	Class II	2004-09-29
K042233	Passing Needle with Ethibond, Panacryl or Orthocord Suture	DePuy Mitek, Inc.	GAM	Class II	2004-09-28
K042141	Polyglytone 6211 Synthetic Absorbable Suture	Teleflex Medical	GAM	Class II	2004-09-28
K041905	Hemosil Calibration Plasma	Instrumentation Laboratory Co.	JIX	Class II	2004-09-28
K041868	Valupen,profile	ConMed Corporation	GEI	Class II	2004-09-28
K041835	Endotine Midface B 4.5 Device	Coapt Systems, Inc.	HWC	Class II	2004-09-28
K041783	Polar Wand	Chek-Med Systems	GEH	Class II	2004-09-28
K041724	Compass M10 System	Medcare Flaga	MNR	Class II	2004-09-28
K041587	Ligasure Precise Model #Ls1200/ligasure 5Mm Laparoscopic Sealer Divider Model # Ls1500	Medtronic, Inc.	GEI	Class II	2004-09-28
K041560	Flo-Assistant	Northgate Technologies Inc.	HIF	Class II	2004-09-28
K041079	Guan Hong Ultrasonic Nebulizer, Model Dr-103/Ac-103	Guan Hong Enterprise Co., Ltd.	CAF	Class II	2004-09-28
K040921	Cooltouch, Model Ns 160	Cooltouch Corp.	GEX	Class II	2004-09-28
K040549	Cosmed Pony Fx	Cosmed S.r.l.	BTY	Class II	2004-09-28
K042507	Ubipacs	Icm Co., Ltd.	LLZ	Class II	2004-09-27
K042334	Allura 3D-Ca, Release 1	Philips North America LLC	LLZ	Class II	2004-09-27
K042303	Vitros Immunodiagnostic Products Anti-Hbs Controls	Ortho-Clinical Diagnostics, Inc.	JJX	Class I	2004-09-27
K041914	Pallindrome 14.5Fr Chronic Hemodialysis Catheter	Kendall	MSD	Class II	2004-09-27
K042442	Quickread System: Quickread Crp Kit, Model 06085; Quickread 101 Instrument, Model 06088; Quickread Crp Control Set, Mode	Orion Diagnostica, Inc.	DCK	Class II	2004-09-24
K042412	Modified Spacemaker System	United States Surgical, A Division of Tyco Healthc	GCJ	Class II	2004-09-24
K042342	Millennium III 3T-8-Channel Neurovascular Coil	GE Healthcare Coils	MOS	Class II	2004-09-24
K042317	Cervical Plate	Scient'X	KWQ	Class II	2004-09-24
K042312	Jet-X Bar Clamps and Pin Clamps-Non-Magnetic/mr Safe	Smith & Nephew, Inc.	KTT	Class II	2004-09-24
K042203	Leonardo Syngo Cardiology Workstation	Siemens Medical Solutions USA, Inc.	LLZ	Class II	2004-09-24
K042198	Ps Medical Neurosurgical Implants	Medtronic Neurosurgery	JXG	Class II	2004-09-24
K042159	Kodak Color Medical Imager 1000	Eastman Kodak Company	LMC	Class II	2004-09-24
K042158	Kodak Medical Imager 300	Eastman Kodak Company	LMC	Class II	2004-09-24
K042019	Hoffmann II Micro External Fixation System	Howmedica Osteonics Corp	KTT	Class II	2004-09-24
K042012	Teh Lin Power Scooter, Model Tl-822	Teh Lin Prosthetic & Orthopaedic, Inc.	INI	Class II	2004-09-24
K042011	Power Scooter, Model Tl0821	Teh Lin Prosthetic & Orthopaedic, Inc.	INI	Class II	2004-09-24
K041925	St360 Spinal Fixation System	Zimmer Spine, Inc.	KWP	Class II	2004-09-24