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 429 of 3528

510(k) clearances, page 429 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K192696	TriMed ASET Foot Plating System	Trimed Inc	HRS	Class II	2020-01-05
K193431	AlignRT Plus	Vision Rt Inc	IYE	Class II	2020-01-03
K193375	NeuroBlate System	Monteris Medical Corp	GEX	Class II	2020-01-03
K193359	SureMAX Family of Cervical Spacers	Additive Implants	ODP	Class II	2020-01-03
K193239	MPowRx Snoring Solution (also known as Good Morning Snore Solution)	MPOWRX HEALTH and WELLNESS PRODUCTS 2012 Inc.	LRK	Class II	2020-01-03
K193140	Flex Body SPEEDER	Quality Electrodynamics	MOS	Class II	2020-01-03
K192893	Straumann Ceramic Healing Abutments	Straumann USA, LLC	NHA	Class II	2020-01-03
K191501	PALLAS 308/311 Solid-State UV Laser System	Laseroptek	GEX	Class II	2020-01-03
K191195	PiccGuard	Piccguard, LLC	PZW	Class II	2020-01-03
K191056	Conformity stem, cemented	United Orthopedic Corp.	JDI	Class II	2020-01-03
K190669	Endotics	Era Endoscopy S.r.l.	FDF	Class II	2020-01-03
K190243	Z5-Bl	Z-Systems AG	DZE	Class II	2020-01-03
K181546	Dillard Nasal Balloon Catheter	Intuit Medical Products, LLC	LRC	Class I	2020-01-03
K193360	Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard	RadmediX, LLC	KPR	Class II	2020-01-02
K193092	TunneLoc Tibial Fixation Device	Zimmer GmbH	MBI	Class II	2020-01-02
K192599	ASAHI PTCA Guide Wire ASAHI Gaia Next	Asahi Intecc Co., Ltd.	DQX	Class II	2020-01-02
K192457	Elos Accurate Customized Abutment	Elos MedTech Pinol a/S	NHA	Class II	2020-01-02
K192216	Invacare AVIVA FX Power Wheelchair, Model: IFX-20MP	Invacare GmbH	ITI	Class II	2020-01-02
K191907	OptoWire III	Opsens Inc.	DQX	Class II	2020-01-02
K191739	Sterile LeadConfirm	Alpha Omega Engineering Ltd.	GZL	Class II	2020-01-02
K191446	Ureteral Stent Systems, Biliary Drainage Catheters	Boston Scientific Corporation	FAD	Class II	2020-01-02
K191147	OC-Auto SENSOR io iFOB Test	Eiken Chemical Co., Ltd.	OOX	Class II	2020-01-02
K191061	Optilume Basic Urological Balloon Dilation Catheter	Urotronic Inc	KOE	Class II	2020-01-02
K183089	Air Next	Nuvoair AB	BZG	Class II	2020-01-02
K193381	RadCalc Software	Lifeline Software, Inc.	MUJ	Class II	2019-12-31
K192912	AutoMIStar	Apollo Medical Imaging Technology Pty., Ltd.	LLZ	Class II	2019-12-31
K192578	InCore TMT System	Medartis AG	HWC	Class II	2019-12-31
K192444	mCare® Powder Free Nitrile Black Examination Glove	Mercator Medical (Thailand) Ltd.	LZA	Class I	2019-12-31
K192343	Patient Monitor	Shenzhen Creative Industry Co., Ltd	DQA	Class II	2019-12-31
K190990	Digital Thermometer	Xiamen Ants Bro Technology Co., Ltd.	FLL	Class II	2019-12-31
K192655	Depuy Synthes Maxillofacial Portfolio - MR Conditional	Synthes (USA) Products LLC	JEY	Class II	2019-12-30
K192258	Disposable Valve Sets	Zhejiang Chuangxiang Medical Technology Co., Ltd.	ODC	Class II	2019-12-30
K190241	Sterile Latex Surgical Glove, Powder Free	Careglove Global Sdn Bhd	KGO	Class I	2019-12-30
K193403	UroNav System	Invivo Corporation	LLZ	Class II	2019-12-27
K193149	True 3D Viewer Software	Echopixel, Inc.	LLZ	Class II	2019-12-27
K192939	Volumetric Specimen Imager	Clarix Imaging Corp	MWP	Class II	2019-12-27
K192700	Xcam	HDX Will	EHD	Class II	2019-12-27
K192695	InMode System with the Morpheus8 (Fractora) Applicators	Inmode MD, Ltd.	GEI	Class II	2019-12-27
K192196	Medical Radiation Dosimetry System microSTARii	Landauer	IYE	Class II	2019-12-27
K191696	Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft	Cook Biotech Incorporated	OXN	Class II	2019-12-27
K191256	Straumann BLX Ø3.5 mm Implants	Straumann USA, LLC	DZE	Class II	2019-12-27
K191059	Masimo Rad-97 and Accessories	Masimo Corporation	MWI	Class II	2019-12-27
K193050	Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem	Zimmer GmbH	LZO	Class II	2019-12-26
K192768	Temporary Fixation Pins	Eisertech, LLC	JDW	Class II	2019-12-26
K190884	TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool	Datascope Corp.	GDW	Class II	2019-12-26
K190467	iHelmet Hair Growth System	Slinph Technologies Co., Ltd	OAP	Class II	2019-12-26
K192135	VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33)	Terumo Cardiovascular Systems Corporation	DQY	Class II	2019-12-24
K193279	Comet II Pressure Guidewire	Boston Scientific Corporation	DXO	Class II	2019-12-23
K193254	3M Attest Steam Chemical Integrator	3M Company	JOJ	Class II	2019-12-23
K192733	RelieforMe TENS/EMS Device Model UPK-GE01	Umeheal, Ltd.	IPF	Class II	2019-12-23