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 745 of 3530

510(k) clearances, page 745 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K141942	Midline II Ti	Centinel Spine, LLC	OVD	Class II	2014-11-07
K141771	Prosigna Breast Cancer Prognostic Gene Signature Assay	Nanostring Technologies	NYI	Class II	2014-11-07
K141644	Innovasis Cranial System	Innovasis, Inc	GWO	Class II	2014-11-07
K140732	Candela Gentlelase Family of Laser Systems	Candela Corporation	GEX	Class II	2014-11-07
K140389	Chloraderm Antimicrobial Transparent Thin Film Dressing, 2 3/8 X 2 3/4, 4 X 4 3/4	Entrotech Life Sciences, LLC	FRO	Unclassified	2014-11-07
K133980	Pantheon Electrostimulator	Pantheon Research	BWK	Unclassified	2014-11-07
DEN130019	Zanza-Click	Tecnimed S.r.l.	OSG	Class II	2014-11-07
DEN100024	Zap-It!	Ecobrands, Ltd.	OSG	Class II	2014-11-07
K142684	FlexCath Select Steerable Sheath (10 French)	Medtronic CryoCath LP	DYB	Class II	2014-11-06
K142640	Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL Sequenstial Circulator, Model SC-2008-DL Sequential Circulator, Model SC-3008-DL Sequential Circulator	Bio Compression Systems, Inc.	JOW	Class II	2014-11-06
K142187	Link Mp Reconstruction Prosthesis	Waldemar Link GmbH & Co. KG	LZO	Class II	2014-11-06
K142016	Capri	K2M, Inc	MQP	Class II	2014-11-06
K141993	Nakoma Acp	Alliance Partners, LLC	KWQ	Class II	2014-11-06
K141887	Obsidian Press (All Ceramic and Pom)	Prismatik Dentalcraft, Inc.	EIH	Class II	2014-11-06
K141674	Cusa Excel+ Ultrasonic Surgical Aspirator System	Integra LifeSciences Corporation	LFL	Unclassified	2014-11-06
K141668	Cusa Excel+ Ultrasonic Surgical Aspirator System	Integra LifeSciences Corporation	LFL	Unclassified	2014-11-06
K141555	Advantage	Lutronic Corporation	GEX	Class II	2014-11-06
K140853	Stimpod St2-3010 Nerve Stimulator	Xavant Technology (Pty) Ltd	BXN	Class II	2014-11-06
K140727	Cutera Picosecond Laser System	Cutera Inc	GEX	Class II	2014-11-06
K140691	Ig_plex Celiac Dgp Panel	Sqi Diagnostics Systems	MVM	Class II	2014-11-06
K140502	Zoll E Series Als	ZOLL Medical Corporation	LDD	Class II	2014-11-06
K140355	Sensiflex Plus Sterile Latex Surgical Glove Powderfree with Protein Content Labeling Claim	Terang Nusa (Malaysia) Sdn. Bhd.	KGO	Class I	2014-11-06
K140246	Yongfa	Yongfa Glove Co., Ltd.	LYZ	Class I	2014-11-06
K140244	Yonghe	Yonghe Plastic Products Co., Ltd.	LYZ	Class I	2014-11-06
K140130	X-Alt Highly Cross Linked Acetabular Liners with Vitamin E, Neutral, 10 Degree Hooded, 20 Degree Hooded	Encore Medical, LP	OQG	Class II	2014-11-06
K133898	Niox Vero Airway Inflammation Monitor	Aerocrine AB	MXA	Class II	2014-11-06
K133166	Ins Hilden Tibial Arzzt	Truemed Group, LLC	HSB	Class II	2014-11-06
K142950	Acrobat Calibrated Tip Wire Guide	Wilson-Cook Medical Inc.	OCY	Class II	2014-11-05
K142470	E-Shield Multi-paried Subdermal Needle Electrodes	Neuroinvent, Inc.	GXZ	Class II	2014-11-05
K142020	Larval Debridement Therapy Products - Larvae 100/200/300 and Biobag 50/100/200/300/400	Biomonde	NQK	Unclassified	2014-11-05
K141909	Collagen Dental Membrane - Conformable Pp	Collagen Matrix, Inc	NPL	Class II	2014-11-05
K141649	Spex Support Catheter	ReFlow Medical, Inc	DQY	Class II	2014-11-05
K133518	Maxan Anterior Cervical Plate System	Biomet Spine (Aka Ebi, LLC)	KWQ	Class II	2014-11-05
K133507	Guidoss	Nibec Co., Ltd.	NPL	Class II	2014-11-05
K132230	Ice Zirkon Transluzent	Zirkonzahn SRL	EIH	Class II	2014-11-05
K142489	Unimed Disposable ECG lead wires	Unimed Medical Supplies Inc	DSA	Class II	2014-11-04
K141676	Renovis Surgical Porous Acetabular Cup System	Renovis Surgical Technologies, LLC	LPH	Class II	2014-11-04
K141338	Liat Strep a Assay	Iquum, Inc.	PGX	Class II	2014-11-04
K140738	Pass Lp Spinal System	Medicrea International	MNI	Class II	2014-11-04
K140193	Durex Embrace Personal Lubricant	Reckitt Benckiser LLC	NUC	Class II	2014-11-04
K141238	Sterilucent Self-Contained Biological Indicator	Sterilucent, Inc.	FRC	Class II	2014-11-03
K142575	Bard RiteCath Intermittent Urinary Catheter	C.R. Bard Inc	EZD	Class II	2014-10-31
K142517	SoftVue	Delphinus Medical Technologies, Inc.	IYO	Class II	2014-10-31
K142484	Sternal Closure System	Jace Medical, LLC	HRS	Class II	2014-10-31
K142286	NS3000 Holmium Laser System	New Star Lasers, Inc.	GEX	Class II	2014-10-31
K142088	Digital Automatic Wrist Blood Pressure Monitor Swbpm22 Series	Grandway Technology (Shenzhen) Limited	DXN	Class II	2014-10-31
K141941	Spinemask Tracker, Spinemap 3D 3.0-Software,spinemap 3D 3.0-Upgreade, Spinemap 3D 3.0-Enable, Spinemap 3D 3.0-Sales D	Stryker Corporate	OLO	Class II	2014-10-31
K141881	Rapidresults	Ramsoft, Inc.	LLZ	Class II	2014-10-31
K141758	T:slim Insulin Delivery System	Tandem Diabetes Care, Inc.	LZG	Class II	2014-10-31
K141745	Iqqa-Bodyimaging Software	Edda Technology, Inc.	LLZ	Class II	2014-10-31