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 614 of 3529

510(k) clearances, page 614 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K162704	Axium Prime Detachable Coil System	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular	HCG	Class II	2017-01-03
K162423	Haemonetics Cell Saver Elite/Elite+ Autotransfusion System	Haemonetics Corporation	CAC	Class II	2017-01-03
K162084	MOTO Partial Knee System	Medacta International SA	HSX	Class II	2017-01-03
K162940	MultiBand SENSE	Philips Medical Systems Nederland B.V.	LNH	Class II	2016-12-30
K162702	Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression Table	STL International, Inc.	HST	Class I	2016-12-30
K162604	Cranial Reducing Tubes	Medtronic Navigation, Inc	HAW	Class II	2016-12-30
K161654	NuFACE Gel Primer	Carol Cole Company	GYB	Class II	2016-12-30
K163180	Hubble II	Orbbo Surgical, LLC	MAX	Class II	2016-12-29
K162531	Sterispine Cc	Safe Orthopaedics	OVE	Class II	2016-12-29
K162375	Envision 3D: Image Guidance System	7D Surgical, Inc.	OLO	Class II	2016-12-29
K162180	Disposable Insulin Syringe	Berpu Medical Technology Co., Ltd.	FMF	Class II	2016-12-29
K163028	Medline ReNewal Reprocessed Stryker External Fixation Devices	Medline ReNewal	JEC	Class II	2016-12-28
K162696	Kuschall Advance Manual Wheelchair	Invacare GmbH	IOR	Class I	2016-12-28
K162692	Kuschall K-Series Attract Manual Wheelchair	Invacare GmbH	IOR	Class I	2016-12-28
K162686	Kuschall Champion Manual Wheelchair	Invacare GmbH	IOR	Class I	2016-12-28
K162675	Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter	Masimo Corporation	DQA	Class II	2016-12-28
K161959	ClearView cCAD	Clearview Diagnostics, Inc.	LLZ	Class II	2016-12-28
K161613	Hang&Go PAC	RAND S.p.A.	LGZ	Class II	2016-12-28
K160972	Gexfix External Fixation	GEXFIX International Corporation	KTT	Class II	2016-12-28
K163308	Smarto	Jeil Medical Corporation	KIJ	Class I	2016-12-27
K161789	BLUEPRINT Patient Specific Instrumentation	Tornier S.A.S.	KWS	Class II	2016-12-27
K162688	Sysmex CS-2100i	Siemens Healthcare Diagnostics Products Limited	JPA	Class II	2016-12-26
K163539	Ez3D-i / E3	Ewoosoft Co., Ltd	LLZ	Class II	2016-12-23
K163055	Reprocessed Kendall SCD Express Foot Cuff	Medtronic, Inc.	JOW	Class II	2016-12-23
K163018	Zilver 635 Biliary Stent	Cook Ireland Ltd.	FGE	Class II	2016-12-23
K163000	AMPLATZER TorqVue 45x45 Delivery Sheath	Aga Medical Corporation (Wholly Owned by St. Jude Medical Co	DQY	Class II	2016-12-23
K162772	ARIES GBS Assay	Luminex Corporation	NJR	Class I	2016-12-23
K162233	Kurin Blood Culture Collection Set	Pathway, LLC	JKA	Class II	2016-12-23
K162193	XenMatrix AB Surgical Graft	Bard Access Systems, Inc.	PIJ	Class II	2016-12-23
K161299	BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System	Apex Biotechnology Corp.	NBW	Class II	2016-12-23
K160231	Model X-100C CO-Met™ Oximetry System	Nonin Medical, Inc	DQA	Class II	2016-12-23
K163306	Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable	Shockwave Medical, Inc.	PPN	Class II	2016-12-22
K163068	pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent	Q Urological Corporation	FAD	Class II	2016-12-22
K162721	Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator	Alliqua Biomedical, Inc.	NRB	Class II	2016-12-22
K162478	ivWatch	Ivwatch, LLC	PMS	Class II	2016-12-22
K162446	FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion System	Orthofix SRL	MAX	Class II	2016-12-22
K162352	derma+flex QS High Viscosity Tissue Adhesive	Chemence Medical Inc.	MPN	Class II	2016-12-22
K162282	CardioChek Plus Test System, CardioChek Home Test System	Polymer Technology Systems, Inc. D/B/A Pts Diagnostics	CGA	Class II	2016-12-22
K162022	Collagentex Rx-1	Tanses Technologies, Inc.	NHN	Class II	2016-12-22
K161639	Y-Mic	Micron Corp.	ELC	Class II	2016-12-22
K161550	DynaMesh-VENTRAL	Feg Textiltechnik Forschungs- und Entwicklungsgesellschaft	FTL	Class II	2016-12-22
K161467	HydraGuard 10 UltraFilter	Nephros Inc	NHV	Class II	2016-12-22
K161399	Neocis Guidance System	Neocis Inc.	PLV	Class II	2016-12-22
K161127	The Small PLATEAU (PLATEAU-C) Spacer System	Life Spine	ODP	Class II	2016-12-22
K161032	neon3™ universal OCT spinal stabilization	Ulrich GmbH & Co. KG	NKG	Class II	2016-12-22
K160982	Sphynx™	Eden Spine, LLC	KWQ	Class II	2016-12-22
K160981	Patient Monitor	Edan Instruments, Inc.	MHX	Class II	2016-12-22
K160949	Go Dose System	Eli Lilly and Company, Pharmaceutical Delivery Systems	NDC	Class II	2016-12-22
K160925	VPS Rhythm Device with TipTracker Technology	Arrow International, Inc. (A Subsidiary of Teleflex, Inc.)	LJS	Class II	2016-12-22
K160590	Xn Check	Streck LLC	JPK	Class II	2016-12-22