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 304 of 3528

510(k) clearances, page 304 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K211610	Fogarty Occlusion Catheter	Edwards Lifesciences LLC	MJN	Class II	2022-02-14
K203793	RithmID-SD Steerable Diagnostic Electrophysiology Catheter	Synaptic Medical Corporation	DRF	Class II	2022-02-14
K213890	IMICRYL Impression Materials	Imicryl Dis Malzemeleri San. ve Tic. A.S.	ELW	Class II	2022-02-11
K213874	MAVERICK External Fixation System	Smith & Nephew, Inc.	JDW	Class II	2022-02-11
K213664	B. Braun Introcan Safety 2 IV Catheter	B.Braun Medical, Inc.	FOZ	Class II	2022-02-11
K213617	Surgical Face Mask	Megasoft (China) Co.,Ltd.	FXX	Class II	2022-02-11
K213603	SIGNA Artist Evo	GE Healthcare (Tianjin) Company Limited	LNH	Class II	2022-02-11
K213487	ACUSON P500 Ultrasound System	Siemens Medical Solutions USA, Inc.	IYN	Class II	2022-02-11
K213462	EzRay M18 (Model: VMX-P400)	Vatech Co., Ltd.	IZL	Class II	2022-02-11
K213328	Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System	Stryker Corp.	HSB	Class II	2022-02-11
K212885	Actively Trying Personal Lubricant Rose Scented	CC Wellness LLC	PEB	Class II	2022-02-11
K212622	Zyter RPM	Zyter, Inc.	MSX	Class II	2022-02-11
K212570	OsteoPlan System	Osteomed	DZJ	Class II	2022-02-11
K212545	FlexitSystem Knee osteotomy system	Neosteo	HRS	Class II	2022-02-11
K212180	Wearable Breast Pump (Model S12)	Shenzhen TPH Technology Co., Ltd.	HGX	Class II	2022-02-11
K211712	3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallmark Anterior Plate System, NewBridge Laminoplasty Fixation System, CETRA Anterior Cervical Plate System	Orthofix SRL	KWQ	Class II	2022-02-11
K211400	Pulse Oximeter	Beijing Choice Electronic Technology Co., Ltd.	DQA	Class II	2022-02-11
K211248	ArtUs	Telemed	IYN	Class II	2022-02-11
K211024	Electric Breast Pump	Shantou Huihengqi Electronic Technology Co., Ltd.	HGX	Class II	2022-02-11
K203337	PainTB, PainTJ	Ptech Co., Ltd.	NHN	Class II	2022-02-11
K220007	Pure-Vu EVS System	MOTUS GI Medical Technologies Ltd.	FDF	Class II	2022-02-10
K213632	Instylla Delivery Kit	Instylla, Inc.	FMF	Class II	2022-02-10
K212971	NPseal	Guard Medical, Inc.	OKO	Class II	2022-02-10
K211570	Zeolite Hemostatic Gauze	Hangzhou Zeo-Innov Life Technology Co., Ltd.	QSY	Unclassified	2022-02-10
K211327	Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable Electrophysiology Catheters, Khelix Variable Loop Steerable Electrophysiology Catheters	Cathrx	DRF	Class II	2022-02-10
K203811	GPC Intraheal Intramedullary Nailing System	GPC Medical Limited	HSB	Class II	2022-02-10
K202926	Micro Catheter	Shanghai Heartcare Medical Technology Corporation Limited	QJP	Class II	2022-02-10
K202728	Action Trackchair Hawk	Action Manufacturing, Inc.	IPL	Class II	2022-02-10
K202234	NervAlign Nerve Cuff	Renerve Ltd	JXI	Class II	2022-02-10
K220108	SDC4K Information Management System with Device and Voice Control Package	Stryker Corp.	GCJ	Class II	2022-02-09
K214011	Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal System with Titan nanoLOCK™ Surface Technology Navigated Instruments, and CD Horizon™ Solera™ Voyager™ Spinal System Navigated, Guided, and Powered Drivers	Medtronic Sofamor Danek USA Inc	OLO	Class II	2022-02-09
K213918	DeGen Navigated Instrumentation	Degen Medical	OLO	Class II	2022-02-09
K213573	PELNAC Wound Matrix	Gunze Limited	KGN	Unclassified	2022-02-09
K213313	Veinoflow SCD (Model: LBTK-M-I 5006)	Dalian Labtek Science & Development Co Ltd	JOW	Class II	2022-02-09
K213311	Lucy Breast Pump	Willow Innovations Inc.	HGX	Class II	2022-02-09
K213297	Redline	Johns Dental Laboratories	NXC	Class II	2022-02-09
K212705	Actively Trying Personal Lubricant Unfragrance	CC Wellness LLC	PEB	Class II	2022-02-09
K212658	CloudCath Peritoneal Dialysis Drain Set Monitoring System	Cloudcath	FKX	Class II	2022-02-09
K212213	Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System	Cepheid	PQA	Class II	2022-02-09
K212211	Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter	Vascular Solutions LLC	DQY	Class II	2022-02-09
K212167	R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire	Vascular Solutions LLC	DQX	Class II	2022-02-09
K211617	Infrascanner	Infrascan, Inc.	OPT	Class II	2022-02-09
K220047	AcQCross Qx Integrated Transseptal Dilator/Needle	Acutus Medical, Inc.	DYB	Class II	2022-02-08
K213165	Rapid	Ischemaview, Inc.	LLZ	Class II	2022-02-08
K213058	O'Star Nitrile Examination Gloves Powder Free	Star Investment and Trade Joint Stock Company	LZA	Class I	2022-02-08
K211530	PathBuilder Steerable Introducer	Shanghai MicroPort EP MedTech Co., Ltd.	DYB	Class II	2022-02-08
K212431	Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve	Zimmer GmbH	JDG	Class II	2022-02-07
K201191	Elec-LED	Micro-NX Co., Ltd.	EBW	Class I	2022-02-07
K220098	Digital Radiography CXDI-Pro, Digital Radiography D1	Canon, Inc.	MQB	Class II	2022-02-04
K220070	MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens	CooperVision, Inc.	LPL	Class II	2022-02-04