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 606 of 3529

510(k) clearances, page 606 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K163535	my Patch sl	dms-service LLC	DSH	Class II	2017-02-22
K163298	Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016 - 256.0 µg/mL	Liofilchem S.r.l.	JWY	Class II	2017-02-22
K163126	Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue)	Blue Sail Medical Co.,Ltd	LZA	Class I	2017-02-22
K163041	Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E	PT. Medisafe Technologies	LZA	Class I	2017-02-22
K162929	Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker	Stryker Corp.	HAW	Class II	2017-02-22
K162911	Sofia RSV FIA on Sofia 2 analyzer	Ortho-Clinical Diagnostics, Inc.	GQG	Class I	2017-02-22
K162800	BLUEPRINT Patient Specific Instrumentation	Tornier S.A.S.	KWS	Class II	2017-02-22
K162795	PROPHECY INVISION Preoperative Navigation Alignment System	Wrightmedicaltechnologyinc	HSN	Class II	2017-02-22
K161926	ND YAG Q-switch Laser Therapy Machine	Beijing Adss Development Co., Ltd.	GEX	Class II	2017-02-22
K161534	EasyOne Pro Respiratory Analysis System	NDD Medizintechnik AG	BTY	Class II	2017-02-22
K161500	Meg-Torq	Micro-NX Co., Ltd.	EKX	Class I	2017-02-22
K152022	SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION® Spacers, COALITION AGX™ Spacers, INDEPENDENCE® Spacers, FORTIFY®-R Corpectomy Spacers, FORTIFY® I-R Corpectomy Spacers, XPand®-R Corpectomy Spacers, NIKO® Corpectomy Spacers, MONUMENT™ Spacers, ALTERA™ Spacers, MAGNIFY™ Spacers, InterContinental® Plate-Spacer	Globus Medical, Inc.	MAX	Class II	2017-02-22
K151834	BEMER Classic Set, BEMER Pro-Set	BEMER Int. AG	NGX	Class II	2017-02-22
K170258	SpeedLyser Infusion Catheter Kit	Boston Scientific Corporation	QEY	Class II	2017-02-21
K163317	ELECTROmatic	Kaltenbach & Voigt Gmgh	EBW	Class I	2017-02-21
K163273	TRU Legionella	Meridian Bioscience Inc	MJH	Class II	2017-02-21
K163091	VibraPEP	Medica Holdings, LLC	BWF	Class II	2017-02-21
K163051	ClearLumen II Peripheral Thrombectomy System	Walk Vascular, LLC	QEZ	Class II	2017-02-21
K163045	Omron HEM-6400T-Z Wrist Blood Pressure Monitor	Omron Healthcare Co., Ltd.	DXN	Class II	2017-02-21
K162841	VariAx Distal Radius Plating System, VariAx 2 System	Stryker Corp.	HRS	Class II	2017-02-21
K162391	AlignMATE™ Lapidus Arthrodesis System	Arthrosurface, Inc.	HRS	Class II	2017-02-21
K162032	Arrowhead Mini-Rail Fixator	Arrowhead de LLC	KTT	Class II	2017-02-21
K161987	UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure	Dio Corporation	DZE	Class II	2017-02-21
K161894	SurgTech Trauma System	Surgtech, Inc.	HWC	Class II	2017-02-21
K161120	SMR TT Metal Back Glenoid, Bone Graft instruments	Lima Corporate S.p.A.	PHX	Class II	2017-02-21
K163272	AXIOS Stent and Electrocautery Enhanced Delivery System	Boston Scientific Corporation	PCU	Class II	2017-02-18
K162565	VIA 17 Microcatheter	Sequent Medical, Inc.	DQY	Class II	2017-02-18
K163651	ExpressBraid Graft Manipulation	Biomet Manufacturing Corp	GAT	Class II	2017-02-17
K163260	SeptiCyte LAB	Immunexpress, Inc	PRE	Class II	2017-02-17
K163037	Intra medullary endo-transilluminating device (iMET device)	WeMED Bio-Tech, Inc.	HRX	Class II	2017-02-17
K162875	Sentry IVC filter	Novate Medical, Ltd.	DTK	Class II	2017-02-17
K162824	Z-Span Plate System	Zavation	KWQ	Class II	2017-02-17
K162281	CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)	Sebia, Inc.	LCP	Class II	2017-02-17
K161953	ReDe Mask	Tereopneuma	PRK	Class II	2017-02-17
K161411	Care Cycle Connect Application	Respironics, Inc.	MOD	Class II	2017-02-17
K160799	GenNarino	Saliwell Ltd.	LTF	Class II	2017-02-17
K160200	Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set	Cook Incorporated	BWC	Class II	2017-02-17
K170170	Valleylab FT10 Electrosurgical Platform	Medtronic, Inc.	GEI	Class II	2017-02-16
K170103	Laparoscope Lens Shield Device (LENS)	Medeon Biodesign, Inc.	GCJ	Class II	2017-02-16
K163602	Kepler I Cervical Plate System	Orbbo Surgical, LLC	KWQ	Class II	2017-02-16
K163549	ClotTriever Thrombectomy System	Inari Medical, Inc.	QEW	Class II	2017-02-16
K163416	Fiagon Navigation – PointerTube Straight and PointerTube Keat	Fiagon GmbH	PGW	Class II	2017-02-16
K163374	ALLY™ Facet Screws	Providence Medical Technology, Inc.	MRW	Unclassified	2017-02-16
K163165	Am-100	BTL Industries, Inc	NGX	Class II	2017-02-16
K162965	SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction	Integra LifeSciences Braintree Inc.	FTM	Class II	2017-02-16
K162849	Huvex Interspinous Fixation System	Dio Medical Co., Ltd.	PEK	Class II	2017-02-16
K162833	VitriGuard	CooperSurgical, Inc.	MQK	Class II	2017-02-16
K162760	Spine Wave Anterior Cervical Spine System	Spine Wave Inc	OVE	Class II	2017-02-16
K162570	Miromatrix Biological Mesh TW	Miromatrix Medical, Inc.	FTM	Class II	2017-02-16
K162481	RF1400 Active Compression Wrap	Recovery Force, LLC	JOW	Class II	2017-02-16