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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 578 of 3529

510(k) clearances, page 578 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K163177	ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA	Immco Diagnostics, Inc.	MST	Class II	2017-07-28
K163048	Smart Stitching Software System, Image Processing, Radiological	Osko, Inc.	LLZ	Class II	2017-07-28
K162951	TUBETECH IV Administration Set	Douglas Medical Products, Inc	FPA	Class II	2017-07-28
K172041	truFreeze System	CSA Medical	GEH	Class II	2017-07-27
K171905	VISCO 360 Viscosurgical System	Sight Sciences, Inc.	MRH	Class II	2017-07-27
K171423	Nasal Alar SpO2 Sensor	Xhale, Inc.	DQA	Class II	2017-07-27
K171282	Fully Automatic Blood Pressure Monitor	Andon Health Co., Ltd	DXN	Class II	2017-07-27
K170563	3M Comply Hydrogen Peroxide Indicator Tape	3M Company	JOJ	Class II	2017-07-27
K170313	ARIX Ankle Distal Tibia System	Jeil Medical Corporation	HRS	Class II	2017-07-27
K163597	VacLok AT Vacuum Syringe	Merit Medical Systems, Inc.	PUR	Class II	2017-07-27
K163031	Bunegin-Albin Air Aspiration Set	Cook Incorporated	DXE	Class II	2017-07-27
K163005	TIGR Matrix Surgical Mesh	Novus Scientific AB	OWT	Class II	2017-07-27
K162816	SML-OSA2 Appliances	Selane Products, Inc.	LQZ	Class II	2017-07-27
DEN150053	Fetal Pillow	Safe Obstetric Systems, Ltd.	PWB	Class II	2017-07-27
K171727	Hydrocleanse Antimicrobial Skin and Wound Care Solution	Sonoma Pharmaceuticals, Inc.	FRO	Unclassified	2017-07-26
K171515	Nhac 16	LMT Medical Systems GmbH	MOS	Class II	2017-07-26
K170841	BiopSee, Mobile US	Medcom GmbH	LLZ	Class II	2017-07-26
K170812	HygePLUS Alginate Impression Material	Hygedent Inc.	ELW	Class II	2017-07-26
K170769	wireless thermometer	Ech (Changzhou) Medical Instrument Co., Ltd.	FLL	Class II	2017-07-26
K163536	MALDI Biotyper CA (MBT-CA) System, MBT smart CA System	Bruker Daltonik GmbH	PEX	Class II	2017-07-26
K163400	Orbit Inserter	Ypsomed AG	KZH	Class II	2017-07-26
K162867	MagDen Dental Implant System	Shinhung MST Co., Ltd.	DZE	Class II	2017-07-26
K171967	MagVita TMS Therapy System	Tonica Elektronik a/S	OBP	Class II	2017-07-25
K171913	Rubicon 14, 18 and 35 Support Catheters	Boston Scientific Corporation	DQY	Class II	2017-07-25
K171885	Radiance V4	Gmv Soluciones Globales Internet S.A.U.	MUJ	Class II	2017-07-25
K171837	TomoTherapy Treatment Delivery System with iDMS	Accuray Incorporated	IYE	Class II	2017-07-25
K171734	HP PRO Positioning Device	Orfit Industries NV	IYE	Class II	2017-07-25
K171645	CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing 1 gram vial, CoMatryx Collagen Wound Dressing 10 gram bottle	Strukmyer Medical	KGN	Unclassified	2017-07-25
K171630	LumFuse-TP	Precifit Medical, Ltd.	MAX	Class II	2017-07-25
K171255	Monteris Medical NeuroBlate System	Monteris Medical Corp	GEX	Class II	2017-07-25
K170997	CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath	Biosense Webster Inc	DYB	Class II	2017-07-25
K170867	FTRD System Set	Ovesco Endoscopy AG	PKL	Class II	2017-07-25
K170770	CT Midline	Medical Components, Inc.	PND	Class II	2017-07-25
K170600	CARTO 3 EP Navigation System, Version 6.0 and Accessories	Biosense Webster Inc	DQK	Class II	2017-07-25
K170388	ANCHORMAN Tibial Ligament Fixation Device	Summit Medical, LLC	MBI	Class II	2017-07-25
K170305	Spinal Manometer NRFit; Spinal Manometer LUER	Pajunk GmbH Medizintechnologie	FMJ	Class II	2017-07-25
K170073	LightMed Dental Laser System	Lightmed Dentaltechnology Corp.	GEX	Class II	2017-07-25
K170067	Easyret	Quantel Medical	HQF	Class II	2017-07-25
K163062	PHMB Antimicrobial Foam Wound Dressing	Advanced Medical Solutions Limited	FRO	Unclassified	2017-07-25
K162312	Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color	Shen Wei (USA), Inc.	LZA	Class I	2017-07-25
K171962	Klassic HD® Hip System	Total Joint Othopedics, Inc.	LPH	Class II	2017-07-24
K171724	Rampart L Lumbar Interbody Fusion Device	Spineology, Inc.	MAX	Class II	2017-07-24
K171559	True Spinal Fixation System	Innovative Surgical Designs, Inc.	NKB	Class II	2017-07-24
K171364	MP LeFort I Plates	Stryker Corp.	JEY	Class II	2017-07-24
K171285	ARIX Diaphysis System	Jeil Medical Corporation	HRS	Class II	2017-07-24
K170923	JAWS(TM) Nitinol Staple System	Paragon 28	JDR	Class II	2017-07-24
K163486	DRACO Locking Bone Screws; DRACO Compression Screws; DRACO MetaFuse L Plates; DRACO MetaFuse BLP Plates; DRACO MetaFuse MTP Plates, Takú Plates, DuoTakú Plates, Open Wedge Plates, Osteoplate Plates, Plantar Plates, Calcaneus Offset Locking Plates	Hnm Total Recon, LLC	KTT	Class II	2017-07-24
K163295	Infant Transport Mattress Warmer with Disc	Rapid Aid Corp.	IMD	Class I	2017-07-24
K162991	YELLOW 560 Fluorescence Module	Carl Zeiss Meditec Inc	IZI	Class II	2017-07-24
K162858	Nitrilecare Nitrile Examination Gloves Powder Free, Blue, Chemotest	Careplus (M) Sdn Bhd	LZC	Class I	2017-07-24