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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 641 of 3529

510(k) clearances, page 641 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K152960	ELAN 4 Motor System	Aesculap Inc	HBC	Class II	2016-07-22
K152787	ST Internal Fixture System	T-Plus Implant Tech. Co., Ltd.	DZE	Class II	2016-07-22
K150932	Sheath Introducer	Bioteque Corp.	DRE	Class II	2016-07-22
DEN160003	Quantidex qPCR BCR-ABL IS Kit	Asuragen, Inc.	OYX	Class II	2016-07-22
K161404	Genesys Spine Apache® Lateral Lumbar Interbody Fusion System	Genesys Spine	MAX	Class II	2016-07-21
K161369	EVEREST Spinal System	K2m, Incorporated	NKB	Class II	2016-07-21
K160955	Tritanium® PL Cage	Stryker Corp.	MAX	Class II	2016-07-21
K160605	MectaLIF Anterior Stand-Alone	Medacta International SA	OVD	Class II	2016-07-21
K160470	SculpSure	Cynosure, LLC	PKT	Class II	2016-07-21
K160144	rainbow LS Block	GENOSS Co., Ltd.	EIH	Class II	2016-07-21
K160086	SHOFU Enamel Conditioner	Shofu Dental Corp.	EBF	Class II	2016-07-21
K153727	INTRAcel Premium Fractional RF Micro Needle (FRM) System	Jeisys Medical Inc.	GEI	Class II	2016-07-21
K153439	PathLoc-C Posterior Cervical Fixation System	L&K Biomed Co.,Ltd.	NKG	Class II	2016-07-21
K152913	GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle	Creganna Medical Aslo Business AS Cregganna Tactx Medical	DYB	Class II	2016-07-21
K152113	BioHPP - breCAM.BioHPP	Bredent GmbH & Co. KG	EBF	Class II	2016-07-21
K151626	ET III Bio-SA Fixture System	Hiossen, Inc.	DZE	Class II	2016-07-21
K150208	Dakin's Skin and Wound Cleanser	Century Pharmaceuticals, Inc.	FRO	Unclassified	2016-07-21
K161227	VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL)	bioMerieux, Inc.	LON	Class II	2016-07-20
K161138	St. Louis Band	Orthomerica Products, Inc.	OAN	Class II	2016-07-20
K161137	Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload	Cardica, Inc.	GDW	Class II	2016-07-20
K161052	OsteoFab Patient Specific Facial Device	Oxford Performance Materials, Inc.	KKY	Class II	2016-07-20
K160984	MultiScan G-Arm System	Beijing East Whale Imaging Technology Co., Ltd.	OXO	Class II	2016-07-20
K160333	Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider	Medline ReNewal	NUJ	Class II	2016-07-20
K153498	Operio	Toul Meditech AB	ORC	Class II	2016-07-20
K153328	SUNCO Mechanical Wheelchair, model SKW-9003	Danyang Sunco Machinery Co., Ltd.	IOR	Class I	2016-07-20
K153268	NR Line Implant System	Dentium Co., Ltd.	DZE	Class II	2016-07-20
K152905	ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer	Arc Devices Limited	FLL	Class II	2016-07-20
K152731	Xp1100 RF	BTL Industries, Inc	GEI	Class II	2016-07-20
K152599	PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System	OK Biotech Co., Ltd.	NBW	Class II	2016-07-20
K152189	Evotech Ecr	Advanced Sterilization Products (Asp)	FEB	Class II	2016-07-20
K161805	EnCor MRI Introducer Set, EnCor Probe Introducer	Senorx, Inc.	KNW	Class II	2016-07-19
K161443	Ekso™ (version 1.1) and Ekso GT™ (version 1.2)	Ekso Bionics	PHL	Class II	2016-07-19
K161359	6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System	Esaote S.p.A.	IYN	Class II	2016-07-19
K161155	Origin Coxa Vara Hip Stem	Signature Orthopaedics Pty Limited	MEH	Class II	2016-07-19
K160907	DePuy Actis DuoFix Hip Prosthesis	Depuy (Ireland)	MEH	Class II	2016-07-19
K160804	INTRAFIX(TM) Advance Tibial Fastener System	Medos International SARL	MAI	Class II	2016-07-19
K153557	ABPM 7100, Hypertension Management Software	I.E.M. GmbH	DXN	Class II	2016-07-19
K160504	RI Witness Embryology Heated Plate	Research Instruments Ltd	MQG	Class II	2016-07-18
K161920	Comfort Cover	Precision Dynamics Corporation	IZH	Class II	2016-07-15
K161694	Threshold™ Pedicular Fixation System	Spineology, Inc.	NKB	Class II	2016-07-15
K161668	ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)	ConforMIS, Inc.	JWH	Class II	2016-07-15
K161659	FlexSeal Introducer Sheath with Hydrophilic Coating	Libramedical, Inc.	DYB	Class II	2016-07-15
K161407	Ascential IBD PEEKc Spacer	Howmedica Osteonics Corp	ODP	Class II	2016-07-15
K161265	NuVasive® VersaTie System	Nu Vasive, Incorporated	OWI	Class II	2016-07-15
K161223	TransContinental® M Spacers and InterContinental® Plate-Spacers	Globus Medical, Inc.	OVD	Class II	2016-07-15
K160704	myPatch-s	dms-service LLC	DSH	Class II	2016-07-15
K160631	Keos Lumbar IBFD	Keos	MAX	Class II	2016-07-15
K160425	CAD/CAMouflage Milling Bock	Prismatik Dentalcraft, Inc.	EBF	Class II	2016-07-15
K160308	Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT)	Fudakang Industrial Co Ltd	FLL	Class II	2016-07-15
K160271	N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12	San-M Package Co., Ltd.	MSH	Class II	2016-07-15