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 314 of 3528

510(k) clearances, page 314 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K210405	ProTEC-USA EZDoff Gown	Cadillac Products, Inc.	QPC	Class II	2021-12-15
K210223	Transcutaneous Electrical Nerve Stimulator	Top-rank Health Care Co.,Ltd.	NUH	Class II	2021-12-15
K210212	Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair	Psychemedics Corp.	LAF	Class II	2021-12-15
K202823	Innomed NPWT Silicone Foam Dressing	Zhejiang Longterm Medical Technology Co., Ltd	OMP	Class II	2021-12-15
K202822	Helianthus	Metaltronica SpA	MUE	Class II	2021-12-15
K200176	FREEDOM Integrated Syringe Infusion System	Repro-Med Systems, Inc. dba Koru Medical Systems	FRN	Class II	2021-12-15
K213422	EkoSonic Endovascular Device, EKOS+ Endovascular Device	Boston Scientific Corporation	QEY	Class II	2021-12-14
K213029	Nitrile Examination Gloves (Powder free, Blue)	Weihai Hongyu Nonwoven Fabric Products Co.,Ltd	LZA	Class I	2021-12-14
K212958	MRIdian Linac System	Viewray Systems, Inc.	IYE	Class II	2021-12-14
K212904	SeaSpine WaveForm C Interbody System	SeaSpine Orthopedics Corporation	OVE	Class II	2021-12-14
K212832	TimeWaver Frequency	TimeWaver Production GmbH	IPF	Class II	2021-12-14
K212675	Aspira Peritoneal Drainage System	Merit Medical Systems, Inc.	PNG	Class II	2021-12-14
K212574	Surgical Face Mask	Xiantao Deming Healthcare Products Co., Ltd.	FXX	Class II	2021-12-14
K212538	DESS Dental Implants	Terrats Medical, S.L.	DZE	Class II	2021-12-14
K210827	ZEPTO Precision Capsulotomy System	Centricity Vision, Inc.	PUL	Class II	2021-12-14
K210744	Surgical Mask	Chongqing PA Xijia Biotechnology Co., Ltd.	FXX	Class II	2021-12-14
K210481	Instant 20s Indicator	True Indicating LLC	MTC	Class II	2021-12-14
K203716	PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System	Smith & Nephew Medical Ltd	QFC	Class II	2021-12-14
K202848	S2 Pigment Removal System	Lightsense Technologies, Ltd.	GEX	Class II	2021-12-14
K200932	Blood Collection Needles	Vacutest Kima SRL	FMI	Class II	2021-12-14
K213700	MULTIX Impact, MULTIX Impact C	Siemens Medical Solutions USA, Inc.	KPR	Class II	2021-12-13
K213176	Disposable Nitrile Powder-Free Examination Gloves	Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd.	LZA	Class I	2021-12-13
K213069	CoLink NeoFuse Plating System	In2bones USA, LLC	HRS	Class II	2021-12-13
K212925	Disposable Surgical Gown	Henan Robestain Medical Products Co., Ltd.	FYA	Class II	2021-12-13
K212924	Nitrile Examination Gloves	Shanxi Nacosa Medical Technology Co.,Ltd	LZA	Class I	2021-12-13
K212918	Heat StimPlus	Famidoc Technology Co., Ltd	NUH	Class II	2021-12-13
K212890	Nyquist.IQ	Omega Medical Imaging, LLC	JAA	Class II	2021-12-13
K212869	Disposable Surgical Gown, Disposable Reinforced Surgical Gown	Fugou County Shenxiang Manufacturing Co., Ltd.	FYA	Class II	2021-12-13
K212706	SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard	Splintek Inc.	OBR	Unclassified	2021-12-13
K212428	Centerpiece Plate Fixation System	Medtronic Sofamor Danek	NQW	Class II	2021-12-13
K212221	Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer	Diazyme Laboratories, Inc.	DHA	Class II	2021-12-13
K212186	Philips Radiology Smart Assistant	Philips Medical Systems DMC GmbH	KPR	Class II	2021-12-13
K212060	neXus Ultrasonic Surgical Aspirator System	Misonix, LLC	LFL	Unclassified	2021-12-13
K211942	Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)	Shenzhen Osto Technology Company Limited	NGX	Class II	2021-12-13
K211572	Aesculap Slim Clip Applier	Aesculap Inc	HCI	Class II	2021-12-13
K210388	Non Sterile Nitrile Powder Free Examination Gloves – Blue, Green and Black color	Mexpo International, Inc.	LZA	Class I	2021-12-13
K202794	Surgical face mask: F-Y1-A	Jiande Chaomei Daily Chemicals Co., Ltd.	FXX	Class II	2021-12-13
K212899	Disposable Vinyl/Nitrile Blend Medical Examination Gloves	Bytech Dongtai Co., Ltd.	LYZ	Class I	2021-12-11
K212867	Medical Surgical Mask	Nanchang Kanghua Health Materials Co., Ltd.	FXX	Class II	2021-12-11
K212840	Nitrile Gloves (Model: NE01)	Byd Auto Industry Company Limited	LZA	Class I	2021-12-11
K212182	Iconic Nitrile Glove	Iconic Medicare Sdn Bhd	LZA	Class I	2021-12-11
K212085	Siam NTD+ Nitrile Powder-Free Examination gloves	Siam Ntd Corporation Co., Ltd.	LZA	Class I	2021-12-11
K213638	Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein Access Set (TPS002), Traveler 16ga Needle Portal Vein Access Set (TPS003)	Argon Medical Devices, Inc	DYB	Class II	2021-12-10
K213637	JAZZ Solo sensor	Jazz Imaging, LLC dba Jazz Imaging	MUH	Class II	2021-12-10
K213543	NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health	Neuronetics Inc.	OBP	Class II	2021-12-10
K213460	Invictus Spinal Fixation System	Alphatec Spine, Inc.	NKB	Class II	2021-12-10
K213394	Vy Spine™ VySpan™ PCT System	VY Spine, LLC	NKG	Class II	2021-12-10
K212922	Nitrile Examination Gloves	Hsk Medical Apparatus Foshan China Co., Ltd.	LZA	Class I	2021-12-10
K212850	ComfortPro Blue Nitrile Examination Gloves Powder Free	Thai Rubber Industry Company Limited	LZA	Class I	2021-12-10
K212577	DESS Dental Smart Solutions	Terrats Medical, S.L.	NHA	Class II	2021-12-10