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 1422 of 3531

510(k) clearances, page 1422 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K031077	Vectra Epr System and Intelect Epr System	Chattanooga Group, Inc.	IMG	Class II	2003-12-11
K033669	Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws)	Smith & Nephew, Inc.	HRS	Class II	2003-12-10
K033586	Modification to Aurora Ds	Syneron Medical, Ltd.	GEX	Class II	2003-12-10
K033544	Electrical Muscle Stimulator, Models N605 and N607	Everyway Medical Instruments Co., Ltd.	IPF	Class II	2003-12-10
K033537	Selfx Xpert Biliary Stent, Models Ex8l2005, Ex8l3005, Ex8l4005, Ex8l2006, Ex8l3006, Ex8l4006, Ex8s2005, and Ex8s3005	Abbott Medical	FGE	Class II	2003-12-10
K033392	Immediate Stabilizing Implant (Isi)	O Co., Inc.	DZE	Class II	2003-12-10
K033269	Endopath Endocutter Gray Cartridge, Model 6R45m/gray Cartridge Reload	Ethicon Endo-Surgery Inc	OCW	Class II	2003-12-10
K033110	C-Graft	The Clinician'S Preference, LLC	LYC	Class II	2003-12-10
K033025	Tytan Professional /Economy Series Sphygmomanometer, No 710/No 700	Tytan Medical Corp.	DXN	Class II	2003-12-10
K032953	Embrace Wetbond Restoration and Pfm Repair Kit	Pulpdent Corporation	KLE	Class II	2003-12-10
K032855	Stryker Spine Maps System	Howmedica Osteonics Corp	MNH	Class II	2003-12-10
K032841	Moorldi Infrared Laser Doppler Imager, Model Moorld12-Ir	Moor Instruments Ltd.	DPT	Class II	2003-12-10
K032829	Scorpio Low Profile Tibial Tray	Howmedica Osteonics Corp	JWH	Class II	2003-12-10
K032757	A-Dec Self-Contained Water System, Model 0.7 Liter Bottle & 2 Liter Bottle	A-dec, Inc.	EIA	Class I	2003-12-10
K032720	Gem-Stim TENS, Models Gm3xy and Gm3axy	Gemore Technology Co., Ltd.	GZJ	Class II	2003-12-10
K032719	Gm3 Series If TENS, Model Gm3x2if (Where X Is a Parameter of Different Housing)	Gemore Technology Co., Ltd.	LIH	Class II	2003-12-10
K031949	Toronto RF Septostomy Catheter, Model Tsc-50-75	Baylis Medical Co., Inc.	DXF	Class II	2003-12-10
K033737	Allura Xper Fd20	Philips North America LLC	OWB	Class II	2003-12-09
K033184	Lateral Angiographic C-Arm Support Mh-400	Shimadzu Corp.	IZI	Class II	2003-12-09
K033156	Ob1 Obstetrical Doppler	D. E. Hokanson, Inc.	KNG	Class II	2003-12-09
K032690	Misonix Inc. Fs 1000 RF Ultrasonic Surgical Aspirator System	Misonix, LLC	LFL	Unclassified	2003-12-09
K032208	Mona Lisa Aspiration Needle	Fertility Technology Resources, Inc.	MQE	Class II	2003-12-09
K031643	Spirotel, Model 29-1020	Sdi Diagnostics, Inc.	BZG	Class II	2003-12-09
K031599	Cd Leycom Pressure/volume Catheters	CD Leycom	DQO	Class II	2003-12-09
K030370	Redline Anthrax Alert Test	Tetracore, Inc	NPO	Class II	2003-12-09
K033613	Modification to Era 300 Dual Chamber Pacing System Analyzer	BIOTRONIK AG	DTA	Class II	2003-12-08
K033568	Gynecare Tvt Obturator System	Ethicon, Inc	OTN	Class II	2003-12-08
K033137	Potens +	Wada, Inc.	JPA	Class II	2003-12-08
K032970	Acra-Cut Xpress 120	Acra Cut, Inc.	HBF	Class II	2003-12-08
K032827	Kendall Lifetrace Umbilical Blood Collection Kit, Code 56501	Tyco Healthcare	KSR	Class II	2003-12-08
K032812	Endoskeleton Ta Vertebral Body Replacement	DSM Biomedical, Inc.	MQP	Class II	2003-12-08
K031094	Fluid Filled Teethers	Royal King Infant Products Co., Ltd.	KKO	Class II	2003-12-08
K031018	Autogel Pad	Rich-Mar Corp.	MUI	Class II	2003-12-08
K033610	Hdl-Cholesterol Plus 2Nd Generation	Roche Diagnostics GmbH	LBS	Class I	2003-12-05
K033542	Easy Pass Hydrophilic Coated Vascular Guidewire	Galt Medical Corp	DQX	Class II	2003-12-05
K033520	Bluephase	Ivoclar Vivadent, Inc.	EBZ	Class II	2003-12-05
K033519	Cannulated Arthrorivet and Cannulated Rc Arthrorivet	Zimmer GmbH	HRS	Class II	2003-12-05
K032821	Hygia Health Services Reprocessed Blood Pressure Cuff	Hygia Health Services, Inc.	NPP	Class II	2003-12-05
K032810	Duran Band (Model H607h), Duran Ring (Model 610R), Duran Band (Model 610B), Duran Ancore Ring (Model 620R), Duran Ancore	Medtronic Heart Valves	KRH	Class II	2003-12-05
K032222	Immunocardstat Hpsa	Meridian Bioscience Inc	LYR	Class I	2003-12-05
K031649	Sl8/dl8/tl20 Hyperbaric Oxygen Treatment Facilities	Fink Engineering Pty Ltd	CBF	Class II	2003-12-05
K030829	Vpt Meter	Xilas Medical, Inc.	LLN	Class I	2003-12-05
K023414	Mida Algorithm Rev. B	Ortivus AB	DYC	Class II	2003-12-05
K033705	Bobcat Pro Scaler System, Model G-130	Dentsply International, Inc.	ELC	Class II	2003-12-04
K033576	Lifeshield Latex-Free Primary IV Pump Set Distal Microbore Patient Line, Convertible Pin, 72 Inch, with 2 Pressure	Abbott Medical	FPA	Class II	2003-12-04
K033429	Lamitrode Spinal Cord Stimulation Leads	Abbott Medical	GZB	Class II	2003-12-04
K033400	Seno Advantage	GE Medical Systems W-400	LLZ	Class II	2003-12-04
K033190	Vision-Tech Yz Slit Lamp, Model 66	Suzhou 66 Vision Tech Co., Ltd.	HJO	Class II	2003-12-04
K032916	Mirage Activa Mask	ResMed Corp	BZD	Class II	2003-12-04
K032900	Lifespan Reinforced Eptfe Straight Vascular Grafts, Externally Supported Vascular Grafts, Stepped Vascular Grafts	Edwards Lifesciences LLC	DSY	Class II	2003-12-04