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 355 of 3528

510(k) clearances, page 355 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K210436	Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal Toric, Total30 Asphere	Alcon Laboratories	LPL	Class II	2021-04-12
K210087	Athena Surgical RMUS System	Athena Surgical	OTN	Class II	2021-04-12
K203751	OMNIVision system	Corin USA	OLO	Class II	2021-04-12
K203210	Invacare Platinum 5NXG Oxygen Concentrator	Invacare GmbH	CAW	Class II	2021-04-12
K202679	Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3	Mcgovern Medical School	KPS	Class II	2021-04-12
K200919	Idys ALIF 3DTi	Clariance, Inc.	MAX	Class II	2021-04-12
K210018	Disposable Medical Mask	Diasia Biomedical Technology Co., Ltd.	FXX	Class II	2021-04-11
K203012	Surgical Mask	Customfab, Inc.	FXX	Class II	2021-04-11
K202761	Medical Surgical Mask (Non-sterile)	Guangdong Goodfeeling Hygiene Material Tec Co., Ltd.	FXX	Class II	2021-04-11
K191479	Velocity Alpha Highspeed Surgical Drill System	Adeor Medical AG	HBE	Class II	2021-04-11
K210710	PENTAX Medical Video Duedenoscope ED34-i10T2	PENTAX of America, Inc.	FDT	Class II	2021-04-09
K210418	HYPER Focus	Shanghai United Imaging Healthcare Co., Ltd.	KPS	Class II	2021-04-09
K210162	Endoscope Model EI-740D/S	FUJIFILM Corporation	FDS	Class II	2021-04-09
K210068	HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound System	Samsung Medison Co., Ltd.	IYN	Class II	2021-04-09
K203742	IdentiTi ALIF Standalone Interbody System	Alphatec Spine, Inc.	OVD	Class II	2021-04-09
K203681	RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review	Brainlab, Inc.	MUJ	Class II	2021-04-09
K203571	Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens	Acuity Polymers Inc.	HQD	Class II	2021-04-09
K203000	KeyPrint KeySplint Hard	Mycone Dental Supply Co. Inc. (dba Keystone Industries)	MQC	Unclassified	2021-04-09
K202748	Enteral Feeding Catheter	Medcaptain Life Science Co., Ltd.	KNT	Class II	2021-04-09
K202513	Disposable Medical Face Mask-Model FM-04	Shenzhen Jinko Industrial Co., Ltd.	FXX	Class II	2021-04-09
K202325	EasyPoint Blood Collection Plus	Retractable Technologies, Inc.	JKA	Class II	2021-04-09
K202084	DeepLook PRECISE	Deeplook, Inc.	LLZ	Class II	2021-04-09
K201903	Electric breast pump (Models: RH-228 and RH-338)	Cixi Ruihong Electric Appliance Co.,Ltd.	HGX	Class II	2021-04-09
K201563	PuRE PMMA Disc	Quest Dental USA Corp	EBG	Class II	2021-04-09
K193630	hekaDrill	Zethon Ltd	HBC	Class II	2021-04-09
DEN200055	GI Genius	Cosmo Artificial Intelligence - Ai, Ltd.	QNP	Class II	2021-04-09
K210491	Cw120n	Wide Corporation	PGY	Class II	2021-04-08
K210408	DePuy Synthes Variable Angle Locking Patella Plating System	Synthes (USA) Products LLC	HRS	Class II	2021-04-08
K210062	Mectaplug PE II	Medacta International SA	JDK	Class II	2021-04-08
K203550	ActivSight Intraoperative Imaging System	Activ Surgical Inc	OWN	Class II	2021-04-08
K202785	Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9 Pro,Nuewa R9S,Resona 7,Resona 7CV,Resona 7EXP,Resona 7S, Resona 7OB,Resona 7PRO,Imagyn 7,Resona Y Diagnostic Ultrasound System	Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.	IYN	Class II	2021-04-08
K202729	Microlife Upper Arm Automatic Digital Blood Pressure Monitor	Microlife Intellectual Property GmbH	DXN	Class II	2021-04-08
K202632	Electric wheelchair (S7204/S7205)	Dongguan Prestige Sporting Goods Co., Ltd.	ITI	Class II	2021-04-08
K202134	Well Lead All Silicone Foley Catheter with Temperature Sensor	Well Lead Medical Co. Ltd	EZL	Class II	2021-04-08
K210701	CATALYS Precision Laser System	Advanced Medical Optics, Inc.	OOE	Class II	2021-04-07
K210182	PANAMA™ Anterior Cervical Plate (ACP) System	Flospine LLC	KWQ	Class II	2021-04-07
K210106	Nitrile Examination Gloves	Zhenjiang Huayang Latex Products Co., Ltd.	LZA	Class I	2021-04-07
K203520	Blustone Synergy Interbody Fusion System	Blustone Synergy, LLC	ODP	Class II	2021-04-07
K203491	PicoLO Nd: YAG Picosecond Laser System	Laseroptek	GEX	Class II	2021-04-07
K200463	Huber Needle Infusion Set, Safety Huber Needle Infusion Set	Jiangsu Caina Medical Co., Ltd	PTI	Class II	2021-04-07
K210734	Endovascular Dilator and Sets	Cook Incorporated	DRE	Class II	2021-04-06
K210716	CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments	CarboFix Orthopedics Inc.	NKB	Class II	2021-04-06
K210685	AcQCross Qx Integrated Transseptal Dilator/Needle	Acutus Medical, Inc.	DYB	Class II	2021-04-06
K210681	SiteSeal SV	Ensite Vascular	DXC	Class II	2021-04-06
K210554	Physica system	Lima Corporate S.p.A.	MBH	Class II	2021-04-06
K203801	Disposable Surgical Face Mask	Anhui Jiabao Protective Equipments Co., Ltd.	FXX	Class II	2021-04-06
K203673	MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MySpine S2-Alar/Alar Iliac Guides)	Medacta International SA	PQC	Class II	2021-04-06
K202703	Vascutek Gelsoft Plus ERS Vascular Graft	Vascutek, Ltd.	DSY	Class II	2021-04-06
K201457	Auxein Brand Vertaux 5.5 mm Pedicle Screw System	Auxein Medical Private Limited/71164	NKB	Class II	2021-04-06
K201257	MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400)	Arrive Systems, Inc.	NGX	Class II	2021-04-06