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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 388 of 3528

510(k) clearances, page 388 of 3528
K number	Device	Applicant	Product code	Class	Decision date
DEN200010	Spineology Interbody Fusion System	Spineology, Inc.	OQB	Class II	2020-09-18
K202192	STRUXXURE®-L and STRUXXURE®-A Plate System	Nexxt Spine LLC	KWQ	Class II	2020-09-17
K202007	LZI Oxycodone III Enzyme Immunoassay	Lin-Zhi International Inc	DJG	Class II	2020-09-17
K201849	eNAT molecular collection and preservation medium	Copan Italia	QBD	Class II	2020-09-17
K201691	Single-Use Surgical Mask With Ear Loop	Qiqihar Hengxin Medical Supplies, Ltd.	FXX	Class II	2020-09-17
K201686	GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™ Introducer and Catheter Guide, GYNECARE TVT EXACT™ Continence System and Trocar, GYNECARE TVT™ Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVO™ Continence System and Passers and Winged Guide	Ethicon, Inc	OTN	Class II	2020-09-17
K201494	ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card	Advin Biotech, Inc.	DJG	Class II	2020-09-17
K193115	EUROIMMUN Anti-BP230-CF ELISA (IgG)	Euroimmun US Inc.	OEG	Class II	2020-09-17
K182020	Portable Electro-Stimulation Therapy Device	Guangzhou Longest Science & Technology Co., Ltd.	NGX	Class II	2020-09-17
DEN190039	ToothWave™	Home Skinovations, Ltd.	QMJ	Class II	2020-09-17
DEN190032	HemosIL Liquid Anti-Xa	Instrumentation Laboratory Co.	QLU	Class II	2020-09-17
K202406	Butterfly iQ Ultrasound System	Butterfly Network, Inc.	IYN	Class II	2020-09-16
K202394	EOSedge	EOS imaging	KPR	Class II	2020-09-16
K202360	Ziehm Vision RFD 3D	Ziehm Imaging GmbH	OWB	Class II	2020-09-16
K202286	Tulsa-Pro System	Profound Medical Inc.	PLP	Class II	2020-09-16
K201774	Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs	PT. Medisafe Technologies	KGO	Class I	2020-09-16
K201661	Symphony Navigation Ready Instruments and Universal Navigation Adaptor Set	Medos International SARL	OLO	Class II	2020-09-16
K201369	AVA (Augmented Vascular Analysis)	See-Mode Technologies Pty Ltd	LLZ	Class II	2020-09-16
K201298	Vx1	Volta Medical	DQK	Class II	2020-09-16
K200469	PAPAYA 3D Premium & PAPAYA 3D Premium Plus	Genoray Co., Ltd.	OAS	Class II	2020-09-16
K200430	Precice® Ankle Salvage System	NuVasive Specialized Orthopedics, Inc.	HSB	Class II	2020-09-16
K202347	UNIFUSE Infusion System with Cooper Wire	Boston Scientific Corporation	QEY	Class II	2020-09-15
K201665	Collaboration Live	Philips North America LLC	LLZ	Class II	2020-09-15
K201664	FIREBIRD SI Fusion System	Orthofix SRL	OUR	Class II	2020-09-15
K201656	ARIX Elbow System	Jeil Medical Corporation	HRS	Class II	2020-09-15
K201645	Massage Compression Boots	JKH USA, LLC	IRP	Class II	2020-09-15
K201341	AcQMap 3D Imaging and Mapping Catheter	Acutus Medical, Inc.	MTD	Class II	2020-09-15
K201170	Athletis PTA Balloon Dilatation Catheter	Boston Scientific Corporation	LIT	Class II	2020-09-15
K192665	Accelerate Pheno System, Accelerate PhenoTest BC Kit	Accelerate Diagnostics, Inc.	PRH	Class II	2020-09-15
K202318	Marathon Flow Directed Micro Catheter	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular	KRA	Class II	2020-09-14
K202227	Artus™ cervical plate system	Ulrich GmbH & Co. KG	KWQ	Class II	2020-09-14
K201646	Shoreline ACS (Anterior Cervical System)	SeaSpine Orthopedics Corporation	OVE	Class II	2020-09-14
K201631	VersaWrap Nerve Protector	Alafair Biosciences, Inc.	JXI	Class II	2020-09-14
K200862	Feelix Stethoscope	Sonavi Labs, Inc.	DQD	Class II	2020-09-14
K200343	FusionFrame Ring Lock System	Glw Medical Innovation	KTT	Class II	2020-09-14
K200313	Vivo	Catheter Precision, Inc.	DQK	Class II	2020-09-14
K193657	Disposable Enteral Feeding Syringe with Enfit Connector	Shinva Ande Healthcare Apparatus Co., Ltd.	PNR	Class II	2020-09-12
K202297	Aline Ablation Intelligence	Mirada Medical Limited	LLZ	Class II	2020-09-11
K202187	FLEX Vessel Prep System	VENTUREMED GROUP, Inc	PNO	Class II	2020-09-11
K202143	Dynex Micro	Vilex LLC	KTT	Class II	2020-09-11
K201959	DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System	DePuy Synthes	HRS	Class II	2020-09-11
K201859	Porcine Mineral Collagen Composite Moldable	Collagen Matrix, Inc	NPM	Class II	2020-09-11
K201779	HotDog Temperature Management Controller	Augustine Temperature Management, LLC	DWJ	Class II	2020-09-11
K201570	PF4 Enhanced assay	Immucor GTI Diagnostics, Inc.	LCO	Class II	2020-09-11
K201506	Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System	Meditech Spine, LLC	ODP	Class II	2020-09-11
K201333	SABER .035 PTA Dilatation Catheter	Cordis US Corp.	LIT	Class II	2020-09-11
K201315	PERFORM Humeral System – Stem	TORNIER Inc.	PAO	Class II	2020-09-11
K200948	Fitbit ECG App	Fitbit LLC	QDA	Class II	2020-09-11
K200854	DePuy PINNACLE Dual Mobility Liner	Depuy Ireland UC	LPH	Class II	2020-09-11
K200530	AMICUS Separator System	Fresenius Kabi AB	GKT	Class II	2020-09-11