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 639 of 3529

510(k) clearances, page 639 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K160542	5.0 Fr Arndt Endobronchial Blocker Set	Cook Incorporated	CBI	Class II	2016-08-02
K160467	Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim	Kossan International Sdn Bhd	LZA	Class I	2016-08-02
K151824	Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs, Powder Free Nitrile Patient Examination Glove, White Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs	Kossan International Sdn Bhd	LZA	Class I	2016-08-02
K161199	EndyMed Contour Handpiece	Endymed Medical Inc.	PBX	Class II	2016-08-01
K160999	Infra-red forehead thermometer	Hangzhou Hua'an Medical & Health Instruments Co.	FLL	Class II	2016-08-01
K160938	SynergEyes SiH with Hydra-PEG(petrafocon A hem-larafilcon A) Hybrid Daily Wear Lens	Synergeyes, Inc.	HQD	Class II	2016-08-01
K160937	Senolris	GE Healthcare	LLZ	Class II	2016-08-01
K160932	8ch Foot Ankle Coil	Shenzhen RF Tech Co., Ltd.	MOS	Class II	2016-08-01
K160856	SpineView X-Pac Expandable Lumbar Cage System	Spine View, Inc.	MAX	Class II	2016-08-01
K160699	VIRTU Lumbar Spacer System	Met 1 Technologies, LLC	MAX	Class II	2016-08-01
K160664	Aqueduct 100 Cervical Dilator	Gtimd, LLC	PON	Class II	2016-08-01
K160414	Precision Point Biopsy Needle Guide	Corbin Clinical Resources, LLC	ITX	Class II	2016-08-01
K160275	Fuse Endoscopic System with FuseBox Processor	Boston Scientific Corporation	PEA	Class II	2016-08-01
K153352	Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody System	Spinal Elements, Inc	OVE	Class II	2016-08-01
K153205	IDSS ForceTriad Control Module	Black Diamond Video, Inc.	ODA	Class II	2016-08-01
K153065	The Hammertoe Correction System	Life Spine	HWC	Class II	2016-08-01
DEN140040	Nautilus BrainPulse 1000	Jan Medical, Inc.	POP	Class II	2016-08-01
K161427	Pirouette 035	Arravasc Limited	LIT	Class II	2016-07-30
K160961	Mozec NC-Rx PTCA Baloon Dilatation Catheter	Meril Life Sciences Private Limited	LOX	Class II	2016-07-30
K161849	Bright	Tanda Beauty Canada, Inc.	OHS	Class II	2016-07-29
K161839	2D Quantitative Analysis	Philips Medical Systems Nederland B.V.	OWB	Class II	2016-07-29
K161801	CrossCath Support Catheter	Cook Incorporated	KRA	Class II	2016-07-29
K161627	PASS LP Spinal System	Medicrea International	NKB	Class II	2016-07-29
K161563	Allura Xper FD series and Allura Xper OR Table series	Philips Medical Systems Nederland B.V.	OWB	Class II	2016-07-29
K161558	Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable Bipolar Ablator 55°, Non-Aspirating, Bovie 1.8mm Disposable Bipolar Ablator 60°, Non-Aspirating	Apyx Medical Corporation	GEI	Class II	2016-07-29
K161507	Cianna Medical SAVI Scout Reflector and SAVI Scout System	Cianna Medical, Inc.	PDW	Class II	2016-07-29
K161499	VertiForm Posterior Fixation System	Next Orthosurgical	NKB	Class II	2016-07-29
K161256	TheraCem	Bisco Inc	EMA	Class II	2016-07-29
K161058	Cannulated Screw	Miami Device Solutions, LLC	HWC	Class II	2016-07-29
K160477	The Luco Hybrid OSA Appliance	Luco Hybrid Osa Appliance, Inc.	OCO	Unclassified	2016-07-29
K160256	Polux , Minerva and Atropos PTA Balloon Dilatation Catheter	BrosMed Medical Co.,Ltd.	LIT	Class II	2016-07-29
K160107	DiamondTOUCH Inflation Device and Fluid Dispensing Syringe	Merit Medical Systems, Inc.	DXT	Class II	2016-07-29
K160082	Puritan Opti-Tranz Cary-Blair Collection and Transport System	Puritan Medical Products Company, LLC	JSM	Class I	2016-07-29
K160038	UniStrip1 Generic Blood Glucose Test Strips	OK Biotech Co., Ltd.	NBW	Class II	2016-07-29
K153732	Powder Free Blue Nitrile Examination Glove	Qube Medical Product Sdn Bhd	LZA	Class I	2016-07-29
K153493	Clip Flow	Voco GmbH	EBF	Class II	2016-07-29
K153296	MEDINAUT Kyphoplasty System	Imedicom Co., Ltd.	NDN	Class II	2016-07-29
K152087	HeatLux Pro II	Home Skinovations, Ltd.	ILY	Class II	2016-07-29
K161899	ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls	Phadia AB	DGC	Class II	2016-07-28
K161787	ACUSON NX2 Diagnostic Ultrasound Systems	Siemens Medical Solutions USA, Inc.	IYN	Class II	2016-07-28
K161771	Medilas H Laser Fibers	Dornier Medtech America, Inc.	GEX	Class II	2016-07-28
K161669	Waterlase Express	Biolase, Inc.	GEX	Class II	2016-07-28
K161631	Mammi	General Equipment for Medical Imaging, S.A.	KPS	Class II	2016-07-28
K161509	3D OCT-1 Maestro	Topcon Corp.	OBO	Class II	2016-07-28
K161382	LVivo Software Application	Diacardio, Ltd.	LLZ	Class II	2016-07-28
K161118	SIMPLANT Online Case Review and SIMPLANT Editor	Dentsply Sirona Inc	LLZ	Class II	2016-07-28
K161020	XSTAT-12, 3-Pack, XSTAT-12, 1-Pack	Revmedx Inc	PGZ	Class II	2016-07-28
K161008	Polyisoprene Powder Free Surgical Underglove, Polyisoprene Powder Free Surgical Glove	Hartalega Sdn Bhd	KGO	Class I	2016-07-28
K160935	8ch Foot Ankle Coil	Shenzhen RF Tech Co., Ltd.	MOS	Class II	2016-07-28
K160910	Elecsys Syphilis	Roche Diagnostics GmbH	LIP	Class II	2016-07-28