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 596 of 3529

510(k) clearances, page 596 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K163415	SlimShape System	Syneron Medical, Ltd.	GEI	Class II	2017-04-20
K163235	Hem-9210T	Omron Healthcare Co., Ltd.	DXN	Class II	2017-04-20
K163160	Sterile Single-use Infusion Set	Jiangxi Hongda Medical Equipment Group Ltd.	FPA	Class II	2017-04-20
K162901	Penumbra 3D Revascularization Device	Penumbra Inc.	NRY	Class II	2017-04-20
K162722	HyperSense	GE Healthcare	LNH	Class II	2017-04-20
K162607	BeneVision Central Monitoring System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	MSX	Class II	2017-04-20
K162354	Sniper Staple System	Trilliant Surgical LLC	JDR	Class II	2017-04-20
K162236	Ax Stand-Alone ALIF System	Innovasis, Inc	OVD	Class II	2017-04-20
K162151	PENTAX Medical ENT Video Imaging System	PENTAX of America, Inc.	EOB	Class II	2017-04-20
K162017	Ross Ru Wound Dressing Gel	Biotd S.A.	FRO	Unclassified	2017-04-20
K161910	Cardinal Health Sterilization Wrap	Cardinal Health200, LLC	FRG	Class II	2017-04-20
K152830	K3	OSSTEM Implant Co., Ltd.	EIA	Class I	2017-04-20
K170215	LaserDock, HolmiumDock, CO2Dock,OmniDock, KTPDock	Patient Pocket, LLC	GEX	Class II	2017-04-19
K170052	Stellaris Elite vision enhancement system	Bausch+Lomb	HQC	Class II	2017-04-19
K163383	GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND Of DHS/Dynamic Condylar Plate Plating System	Greens Surgicals Pvt., Ltd.	HRS	Class II	2017-04-19
K161884	Ortho System	3Shape A/S	MQC	Unclassified	2017-04-19
K160680	VisioFocus Mini, VisioFocus Smart	Tecnimed S.r.l.	FLL	Class II	2017-04-19
K160502	TEG 6s Hemostasis System	Haemonetics Corporation	JPA	Class II	2017-04-19
K170593	Mako Total Hip Application	Mako Surgical Corp.	OLO	Class II	2017-04-18
K170533	Model 330 Multifunction Aspirator	ZOLL Medical Corporation	BTA	Class II	2017-04-18
K170406	Plato MICROCATH 27B Microcatheter	Scientia Vascular	DQO	Class II	2017-04-18
K170247	Lacriflow CL	Kaneka Pharma America, LLC	OKS	Unclassified	2017-04-18
K170120	EndoRotor	Interscope, Inc.	PTE	Class II	2017-04-18
K163523	ECHELON CIRCULAR Powered Stapler	Ethicon Endo-Surgery Inc	GDW	Class II	2017-04-18
K163387	PICO Single Use Negative Pressure Wound Therapy System	Smith & Nephew Medical Ltd	OMP	Class II	2017-04-18
K162297	Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set	Diazyme Laboratories, Inc.	PTF	Class II	2017-04-18
K162296	OmniPod Insulin Management System	Insulet Corporation	LZG	Class II	2017-04-18
K162087	NovoGro	Osteonovus, Inc.	MQV	Class II	2017-04-18
K160967	Finapres Nova Noninvasive Hemodynamic Monitor	Finapres Medical Systems B.V.	DXN	Class II	2017-04-18
K170833	EndoFLIP® System with FLIP Topography module	Crospon, Ltd.	FFX	Class II	2017-04-17
K163484	Paxman Scalp Cooler	Paxman Coolers Limited	PMC	Class II	2017-04-17
K163001	PowerFlow Apheresis I.V. Port	C.R. Bard Inc	PTD	Class II	2017-04-17
K162621	Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair	Invacare GmbH	IOR	Class I	2017-04-17
K162361	Soft Plug Extended Duration 180 Canalicular Plug	Oasis Medical, Inc.	LZU	Unclassified	2017-04-17
K162108	Pressio 2 ICP Monitoring System	Sophysa	GWM	Class II	2017-04-17
K170643	Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	MAX	Class II	2017-04-14
K170582	Saf-T-Vac Smoke and Fluid Evacuator	Surgical Technology Laboratories Inc.	GEI	Class II	2017-04-14
K170268	Fortress™ Pedicular Fixation System	Spineology, Inc.	NKB	Class II	2017-04-14
K170266	Palisade™ Pedicular Fixation System	Spineology, Inc.	NKB	Class II	2017-04-14
K170255	Threshold™ V2 Pedicular Fixation System	Spineology, Inc.	NKB	Class II	2017-04-14
K170251	Threshold™ Pedicular Fixation System	Spineology, Inc.	NKB	Class II	2017-04-14
K163656	Hoffmann LRF System	Stryker Corp.	KTT	Class II	2017-04-14
K163581	Navigated ELEVATE Inserter, Navigated Disc Prep Instruments	Medtronic Sofamor Danek USA Inc	OLO	Class II	2017-04-14
K163381	HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable	Edwards Lifesciences LLC	DQK	Class II	2017-04-14
K163329	Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72	Pulsaderm, LLC	OHS	Class II	2017-04-14
K163171	CeraClean	Bisco Inc	PME	Class II	2017-04-14
K162891	Complete Control System	Coapt LLC	GXY	Class II	2017-04-14
K162785	Velox Nebulizer System	Pari Respiratory Equipment, Inc.	CAF	Class II	2017-04-14
K162636	Marco Ultra M3, Marco Ultra M4	Takagi Seiko Co., Ltd.	HJO	Class II	2017-04-14
K162517	Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13	JKH Health Co., Ltd.	NUH	Class II	2017-04-14