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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 689 of 3530

510(k) clearances, page 689 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K152177	SonoStik IV Guide Wire Introducer	Sonostik, LLC	DYB	Class II	2015-10-01
K151952	Synergy ODM	Topcon Healthcare, Inc.	NFJ	Class II	2015-10-01
K151011	Visera 4K Uhd System	Olympus Medical Systems Corp.	HET	Class II	2015-10-01
K150694	3M Comply Hydrogen Peroxide Indicator Tape 1228	3M Company	JOJ	Class II	2015-10-01
K150221	EPX-4440HD and EPX-4400HD with FICE	FUJIFILM Healthcare Americas Corporation	FET	Class II	2015-10-01
K150031	hemoFISH Masterpanel	Miacom Diagnostics GmbH	JSS	Class I	2015-10-01
K143515	Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and Nobel Biocare NobelReplace Implants	Prismatik Dentalcraft, Inc.	NHA	Class II	2015-10-01
K142887	SIS Inguinal Hernia Repair Graft	Cook Biotech Incorprated	FTM	Class II	2015-10-01
K152524	Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable Gastrointestinal Suture Anchor Set	Cook Incorporated	FGE	Class II	2015-09-30
K151849	Seneka I Polyscrew Pedicle Fixation System	Senecka Spine	NKB	Class II	2015-09-30
K151280	MultiScan G-Arm System	Beijing East Whale Imaging Technology Co., Ltd.	OXO	Class II	2015-09-30
K151149	Ready-Fit	Den Tek Oral Care, Inc.	OBR	Unclassified	2015-09-30
K151079	Q2 Intravenous Adminstration Sets and Extension Sets	Quest Medical, Inc	FPA	Class II	2015-09-30
K150565	Supria Whole-body X-ray CT System	FUJIFILM Healthcare Americas Corporation	JAK	Class II	2015-09-30
K150078	PowerDot(R) PD-01 Muscle Stimulator (with PowerDot(R) Mobile Application)	Smartmissimo Technologies Pte, Ltd.	NGX	Class II	2015-09-30
K143245	GPC Intramedullary Nailing Systems	GPC Medical Limited	HSB	Class II	2015-09-30
K142928	FreeStyle Precision Neo Blood Glucose Monitoring System	Abbott Medical	NBW	Class II	2015-09-30
K140827	SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set	SD Biosensor, Inc.	LCP	Class II	2015-09-30
K152483	Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series	Grandway Technology (Shenzhen) Limited	DXN	Class II	2015-09-29
K152195	Logiq S8	GE Healthcare	IYN	Class II	2015-09-29
K151777	Intradermal Adapter	West Pharmaceutical Services, Inc.	FMF	Class II	2015-09-29
K151761	SureSigns VS3, SureSigns VS4	Phillips Medical Systems	DSJ	Class II	2015-09-29
K151579	MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fit	Siemens Medical Solutions USA, Inc.	LNH	Class II	2015-09-29
K151576	Neon EEG	Incereb Ltd	GXY	Class II	2015-09-29
K151100	U-RIGHT TD-4116 Blood Glucose Monitoring System, U-RIGHT TD-4116 Pro Blood Glucose Monitoring System	Taidoc Technology Corporation	NBW	Class II	2015-09-29
K150998	HEARTWAY Power Mobility Scooter	Heartway Medical Products Co., Ltd.	INI	Class II	2015-09-29
K150654	Cholesterol	Randox Laboratories, Limited	CHH	Class I	2015-09-29
K150622	3M Comply Hydrogen Peroxide Chemical Indicator 1248	3M Company	JOJ	Class II	2015-09-29
DEN150002	EarLens Contact Hearing Device	Earlens Corporation	PLK	Class II	2015-09-29
K152488	Onrad Treatment System	Accuray Incorporated	MUJ	Class II	2015-09-28
K152171	Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4	Orthofix SRL	KTT	Class II	2015-09-28
K152158	ARIX Ankle System	Jeil Medical Corporation	KTT	Class II	2015-09-28
K152437	BiowaveHOME Neuromodulation Pain Therapy Device	Biowave Corporation	GZJ	Class II	2015-09-25
K152193	Renovis Anterior Cervical Plate System	Renovis Surgical Technologies, LLC	KWQ	Class II	2015-09-25
K152132	X-spine Pedicle Screw System	Xtant Medical Holdings, Inc.	MNI	Class II	2015-09-25
K151809	Alere Afinion HbA1c, Alere Afinion AS100 Analyzer	Alere Technologies AS	LCP	Class II	2015-09-25
K151651	NuVasive X-CORE Mini Cervical Expandable VBR System	Nu Vasive, Incorporated	PLR	Class II	2015-09-25
K151358	AZUR CX Detachable 35 Coils	Terumo Cardiovascular Systems Corporation	KRD	Class II	2015-09-25
K150862	DePuy Actis Duofox Hip Prosthesis	Depuy Orthopaedics Inc.	MEH	Class II	2015-09-25
K150832	U2 Femoral Component, CR, Porous Coated, Additional Sizes	United Orthopedic Corp.	MBH	Class II	2015-09-25
K150829	U2 Total Knee System- Additional Sizes	United Orthopedic Corp.	JWH	Class II	2015-09-25
K150402	Endoluminal Occlusion System-EOS	Artventive Medical Group, Inc.	KRD	Class II	2015-09-25
K143479	Bluefin Interbody System	Tides Medical, LLC	MAX	Class II	2015-09-25
K152433	VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7	Ortho-Clinical Diagnostics, Inc.	DCK	Class II	2015-09-24
K152409	Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC	Boston Scientific Corporation	LJS	Class II	2015-09-24
K152281	Pyrenees Cervical Plate System	K2M, Inc	KWQ	Class II	2015-09-24
K152216	SudoC	LD Technology LLC	GZO	Class II	2015-09-24
K152080	Metacross OTW PTA Balloon Dilatation Catheter	KANEKA Corporation	LIT	Class II	2015-09-24
K152069	Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage Catheter	Boston Scientific Corporation	FGE	Class II	2015-09-24
K152064	Astringedent Clear	Ultradent Products Inc.	MVL	Unclassified	2015-09-24