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 448 of 3528

510(k) clearances, page 448 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K190473	ACIST RXi System and Navvus II Catheter	Acist Medical Systems, Inc.	OBI	Class II	2019-09-13
K190288	Arthrex Tenodesis Button	Arthrex GmbH	MBI	Class II	2019-09-13
K190005	Sterilucent HC 80TT Hydrogen Peroxide Sterilizer	Sterilucent, Inc.	MLR	Class II	2019-09-13
K183670	Vexillum Zephyr (olifilcon A) with Tangible Polymers Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens ; OxyPure A (olifilcon A) Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens	Visco Vision Inc.	LPL	Class II	2019-09-13
K183586	CapMedic	Cognita Labs LLC	CAF	Class II	2019-09-13
K183364	Bellavista	Imtmedical AG	CBK	Class II	2019-09-13
K182921	Infinix Universal Composite	Nobio, Ltd.	EBF	Class II	2019-09-13
K181478	Roosin Xeroform Petrolatum Dressing	Roosin Medical Co., Ltd.	FRO	Unclassified	2019-09-13
K192293	uDR 592h, uDR 596i	Shanghai United Imaging Healthcare Co., Ltd.	KPR	Class II	2019-09-12
K192199	CRC PC Smart Chamber K1	Mirion Technologies (Capintec), Inc.	KPT	Class II	2019-09-12
K192012	Capillus 112, Capillus 244	Capillus, LLC	OAP	Class II	2019-09-12
K191726	mont blanc & mont blanc MIS Spinal Systems	Spineway	NKB	Class II	2019-09-12
K191629	faceLITE	Ismart Marketing Svcs, Ltd.	OHS	Class II	2019-09-12
K191587	L360 Thigh System	Bioness, Inc.	GZI	Class II	2019-09-12
K191518	CO2 Laser System	Shenzhen GSD Tech Co., Ltd	GEX	Class II	2019-09-12
K191516	Ali Interbody Fusion System	Raed M. Ali, M.D., Inc.	MAX	Class II	2019-09-12
K191419	Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire	Rex Medical LP	MCW	Class II	2019-09-12
K191300	MectaLock Ti Suture Anchor	Medacta International SA	MBI	Class II	2019-09-12
K191148	Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set	Medtronic Sofamor Danek USA Inc	PML	Class II	2019-09-12
K190780	syngo Application Software	Siemens Medical Solution USA, Inc.	LLZ	Class II	2019-09-12
K190768	ARTIS icono	Siemens Medical Solutions USA, Inc.	OWB	Class II	2019-09-12
K190398	Republic Spine Restore Intervertebral Body Fusion System	Republic Spine	MAX	Class II	2019-09-12
K190002	Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use	Shanghai Kohope Medical Devices Co., Ltd	FMF	Class II	2019-09-12
K183695	OrthoAnalysis Software	Inteware Co., Ltd	PNN	Class II	2019-09-12
K183662	Saline Wound Wash, SteriCleanse(TM)	Ascent Consumer Products, Inc.	FRO	Unclassified	2019-09-12
K182257	UPnRIDE	Upnride Robotics Ltd	IPL	Class II	2019-09-12
K191811	Catalyst OrthoScience CSR Shoulder System	CATALYST ORTHOSCIENCE Inc	KWT	Class II	2019-09-11
K191619	TurboTemp EZ	Zest Anchors LLC	EBG	Class II	2019-09-11
K191605	Neocis Guidance System (NGS)	Neocis Inc.	PLV	Class II	2019-09-11
K191355	3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask	3M Healthcare	FXX	Class II	2019-09-11
K191301	Ceribell Pocket EEG Device	Ceribell, Inc.	OMB	Class II	2019-09-11
K190815	BrainScope TBI	Brainscope	PIW	Class II	2019-09-11
K183521	CNAP Monitor	CNSYSTEMS MEDIZINTECHNIK GmbH	DXN	Class II	2019-09-11
K183370	PeraMobile and PeraWatch	Perahealth, Inc.	MWI	Class II	2019-09-11
K191945	KOWA nonmyd 8	Kowa Company, Ltd.	HKI	Class II	2019-09-10
K191013	Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option	Welch Allyn Inc	BZG	Class II	2019-09-10
K190683	External Counterpulsation System	Vamed Medical Instrument Co.,Ltd	DRN	Class II	2019-09-10
K190484	BH Medical Dental Barrier Sleeves and Barrier Film	BH Medical Products Co., Ltd	PEM	Class II	2019-09-10
K183268	AI-Rad Companion (Cardiovascular)	Siemens Medical Solutions USA, Inc.	JAK	Class II	2019-09-10
K181614	Sterling Supreme Diode Laser	Cao Group, Inc.	GEX	Class II	2019-09-10
K181602	Pioneer Elite Diode Laser	Cao Group, Inc.	GEX	Class II	2019-09-10
K192172	Connected OR Hub with Device and Voice Control	Stryker Corp.	GCJ	Class II	2019-09-09
K191421	Sofacia System	Sofwave Medical Ltd.	OHV	Class II	2019-09-09
K191354	Ti3Z Cervical Interbody System	Zavation Medical Products, LLC	ODP	Class II	2019-09-09
K190668	Encompass 15 Channel Head Coil, 3T	Qfix	MOS	Class II	2019-09-09
K183444	Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector	Cenorin, LLC	LDS	Class II	2019-09-09
K181601	Precise SHP Diode Laser	Cao Group, Inc.	GEX	Class II	2019-09-09
K183215	Focus TENS Therapy, Model PM710-M/-L	Omron Healthcare Co., Ltd.	NUH	Class II	2019-09-07
K192226	Lumify Diagnostic Ultrasound System	Philips Health Care	IYN	Class II	2019-09-06
K192188	Aquilion ONE (TSX-306A/3) V10.0	Canon Medical Systems Corporation	JAK	Class II	2019-09-06