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 356 of 3528

510(k) clearances, page 356 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K210850	Adas 3D	ADAS3D Medical S.L	LLZ	Class II	2021-04-05
K210130	Stockert S5 System	LivaNova Deutschland GmbH	DTQ	Class II	2021-04-05
K203623	StentBoost Mobile	Philips India Limited	OWB	Class II	2021-04-05
K203567	Oral-B Dry Mouth Oral Rinse	Procter & Gamble Co.	LFD	Unclassified	2021-04-05
K203499	Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank	Vatech Acucera, Inc.	EIH	Class II	2021-04-05
K203480	DOUBLEFLO system	Hemodia SAS	HRX	Class II	2021-04-05
K202655	Disposable Medical Mask	Dongguan Runlin Medical Supplies Technology Co., Ltd.	FXX	Class II	2021-04-05
K210784	Extended HA Half Pins	Smith & Nephew, Inc.	JDW	Class II	2021-04-02
K210692	DigitalDiagnost	Philips Medical Systems DMC GmbH	KPR	Class II	2021-04-02
K210275	Polaris Spinal System	Highridge Medical, LLC	NKB	Class II	2021-04-02
K210251	ClearPath Disposable Introducer	Clearmind Biomedical	GWG	Class II	2021-04-02
K210023	Surgical Face Mask	Guangdong Winsun Personal Care Products Co.,Ltd	FXX	Class II	2021-04-02
K203816	DeGen Navigated Instrumentation	Degen Medical	OLO	Class II	2021-04-02
K203767	Pristine Long-Term Hemodialysis Catheter	C B Bard, Inc.	MSD	Class II	2021-04-02
K203472	KMTI Hip Replacement System	Kyocera Medical Technologies, Inc.	OQG	Class II	2021-04-02
K203310	SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System	Jiangsu Synecoun Medical Technology Co., Ltd.	JOW	Class II	2021-04-02
K203230	Global Shoulder and Delta CTA systems	Depuy Lnc.	KWS	Class II	2021-04-02
K202928	DV. Target	Deepvoxel, Inc.	QKB	Class II	2021-04-02
K202909	CreoDent Solidex Customized Abutment	Creodent Prosthetics Ltd	NHA	Class II	2021-04-02
K202447	Medline Orbis Surgical Gown	MEDLINE INDUSTRIES, LP - Northfield	FYA	Class II	2021-04-02
K202441	Eclipse II with Smart Noise Cancellation	Eastman Kodak Company	MQB	Class II	2021-04-02
K202243	SkinPen Precision System	Crown Aesthetics	QAI	Class II	2021-04-02
K202183	Porcine Mineral Collagen Composite	Collagen Matrix, Inc	NPM	Class II	2021-04-02
K201611	Apex Knee System	Omni Life Science, Inc.	JWH	Class II	2021-04-02
K201171	LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable	Leoni Fiber Optics, Inc.	GEX	Class II	2021-04-02
K210743	ACUSON Redwood Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	IYN	Class II	2021-04-01
K210668	TSolution One Total Knee Application	Think Surgical Inc.	OLO	Class II	2021-04-01
K210340	Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR	Canon Medical Systems Corporation	LNH	Class II	2021-04-01
K210300	VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System	Vuesonic, LLC	LYL	Class II	2021-04-01
K203795	Star RF Electrode, VIVA RF Electrode	Starmed Co.,Ltd	GEI	Class II	2021-04-01
K203782	Nanox Cart X-ray System	Nano-X Imaging Ltd	IZL	Class II	2021-04-01
K203195	Simpleware ScanIP Medical	Synopsys (Northern Europe), Ltd.	LLZ	Class II	2021-04-01
K202768	KOSMO Femoral Stem	b-ONE Ortho Corp.	LZO	Class II	2021-04-01
K202365	Pentax Medical Video Duodenoscope ED32-i10	PENTAX of America, Inc.	FDT	Class II	2021-04-01
K202228	Omron Model BP7900 Blood Pressure Monitor + EKG	Omron Healthcare Co., Ltd.	DXN	Class II	2021-04-01
K202206	AMG PMP Pediatric	Eurosets S.r.l.	DTZ	Class II	2021-04-01
K202154	B-Capta	LivaNova Deutschland GmbH	DRY	Class II	2021-04-01
K202129	Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigma, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyo	Largan Medical Co., Ltd.	LPL	Class II	2021-04-01
K202032	Idys LLIF 3DTi	Clariance-SAS	OVD	Class II	2021-04-01
DEN200038	Gili Pro BioSensor (also known as “Gili BioSensor System”)	Continuse Biometrics, Ltd.	QOK	Class II	2021-04-01
K210654	EnCor Breast Biopsy Probe with Rinse Tube	Senorx, Inc.	KNW	Class II	2021-03-31
K210631	Avitus(r) Bone Harvester	Avitus Orthopaedics, Inc	KNW	Class II	2021-03-31
K210616	Longeviti PMMA Static Cranial Implant	Longeviti Neuro Solutions	GXN	Class II	2021-03-31
K210110	Guidion	IMDS Operations B.V.	DQY	Class II	2021-03-31
K210071	SIS System (Version 5.1.0)	Surgical Information Sciences, Inc.	LLZ	Class II	2021-03-31
K210057	Blue Nitrile Exam Glove, Powder Free	Real Star Medical Technology Co., Ltd.	LZA	Class I	2021-03-31
K203443	MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea	Siemens Medical Solutions USA, Inc.	LNH	Class II	2021-03-31
K203378	Pulsehaler	Respinova, Ltd.	BWF	Class II	2021-03-31
K203258	syngo.CT Lung CAD	Siemens Healthcare GmbH	OEB	Class II	2021-03-31
K203101	Secure Wear USA Surgical Face Mask	Secured Ortho Manufacturing of America, LLC	FXX	Class II	2021-03-31