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 309 of 3528

510(k) clearances, page 309 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K213199	Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System	Stryker Corp.	HWC	Class II	2022-01-11
K213168	Medical Examination Gloves	Shandong Huiwosheng Health Technology Co.,Ltd	LZA	Class I	2022-01-11
K213102	ES1 System	E-Scopics	IYN	Class II	2022-01-11
K212735	Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs)	Xingyu Medical Tech Co.,Ltd	LZA	Class I	2022-01-11
K212591	Disposable Surgical Gown	Suzhou Janee Medical Technology Co., Ltd.	FYA	Class II	2022-01-11
K211851	Ora-Aid	Tbm Corporation	OLR	Unclassified	2022-01-11
K202094	Cardiovascular Suite 4.2.1	Quipu S.R.L	DQK	Class II	2022-01-11
K191356	i3 Foldable Mobility Scooter	Puc Perfect Union Co., Ltd.	INI	Class II	2022-01-11
K213111	MagnetOs granules	Kuros Biosciences BV	MQV	Class II	2022-01-10
K212954	G-Tech Wireless Patch System (WPS)	G-TECH MEDICAL Inc.	MYE	Class II	2022-01-10
K212854	Powered Wheelchair	Zhejiang Qianxi Vehicle Co., Ltd.	ITI	Class II	2022-01-10
K212688	Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger	Spectrum Medical Inc	DTR	Class II	2022-01-10
K212541	3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix	Deltamed GmbH	EBI	Class II	2022-01-10
K212505	DUMI ManipulatOR	The O R Company Pty, Ltd.	LKF	Class II	2022-01-10
K212358	Romero Cervical Cage	Spineup Inc	OVE	Class II	2022-01-10
K211419	Gingi-Aid Gel	Belport Company, Inc., Gingi-Pak	MVL	Unclassified	2022-01-10
K211274	iQ 2 Nasal Mask, Phantom 2 Nasal Mask	SleepNet Corporation	BZD	Class II	2022-01-10
K211260	Sheng Jing Tang Surgical Mask	Liaoning Shengjingtang Biotechnology Co., Ltd.	FXX	Class II	2022-01-10
K212801	Powder free nitrile examination glove- black, non sterile	Hong Seng Gloves Sdn Bhd	LZA	Class I	2022-01-09
K211666	Powder Free Nitrile Examination Gloves, Blue Chemotest	Careglove Global Sdn Bhd	LZA	Class I	2022-01-09
K213901	Cyclops™ Anterior Cervical Plate System	Degen Medical	KWQ	Class II	2022-01-07
K213880	Custom Stable Rigid Gas Permeable Scleral Contact Lens	Valley Contax, Inc	HQD	Class II	2022-01-07
K213720	Vital Navigation System	Zimvie (Zimmer Biomet Spine, Inc.)	OLO	Class II	2022-01-07
K213570	Dental Zirconia Ceramic	Aidite (Qinhuangdao) Technology Co., Ltd	EIH	Class II	2022-01-07
K213262	CELERITY HP Chemical Indicator	STERIS Corporation	QKM	Class II	2022-01-07
K212990	Acumed Ankle Syndesmosis Repair System	Acumed LLC	HTN	Class II	2022-01-07
K212980	Tesera-k ALIF System	Kyocera Medical Technologies, Inc.	OVD	Class II	2022-01-07
K212841	Pectus Blu Support Bar System	Biomet Micofixation	HRS	Class II	2022-01-07
K212166	ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress	Inomed Medizintechnik GmbH	GWF	Class II	2022-01-07
K212152	Prelude IDeal 9F Hydrophilic Sheath Introducer	Merit Medical Systems, Inc.	DYB	Class II	2022-01-07
K212127	Picocaremajesty	WONTECH Co., Ltd.	GEX	Class II	2022-01-07
K211940	Fetal Doppler	Shenzhen Taikang Medical Equipment Co.,Ltd.	KNG	Class II	2022-01-07
K211742	SignaSure Dual Mobility System	Signature Orthopaedics Pty Limited	MEH	Class II	2022-01-07
K211716	DropSafe Safety Pen Needles	HTL-Strefa S.A.	FMI	Class II	2022-01-07
K211443	Aibolit 3D+	Aibolit Technologies, LLC	LLZ	Class II	2022-01-07
K211349	Selebrek PTCA Balloon Dilatation Catheter	Kossel MedTech (Suzhou) Co., Ltd.	LOX	Class II	2022-01-07
K211269	Visualase MRI-Guided Laser Ablation System (SW 3.4)	Medtronic Navigation, Inc	ONO	Class II	2022-01-07
K211110	Agile Devices Angler Steerable, Deflectable Microcatheter	Agile Devices, Inc.	KRA	Class II	2022-01-07
K210564	Infrared Thermometer	Alicn Medical Shenzhen, Inc	FLL	Class II	2022-01-07
K210198	GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Radius Plates, 6 head Holes, GPC 2.4mm Variable Angle Locking Two Column Volar Distal Radius Plates, 7 Head Holes, 2.4 mm Variable Angle Locking Two Column Volar Distal Radius Plate-Narrow, 6 Head Holes, Variable Angle Locking Screw 2.4 mm, Stardrive	GPC Medical Limited	HRS	Class II	2022-01-07
K210039	CORE1 Implant System	Cybermed Inc.	DZE	Class II	2022-01-07
K203360	EK Implants and Abutments System	Hiossen, Inc.	DZE	Class II	2022-01-07
DEN210015	Sunrise Sleep Disorder Diagnostic Aid	Sunrise SA	QRS	Class II	2022-01-07
K213841	ENEO TOTALE (Model: ENEOT947)	Premier North America, Inc	OHS	Class II	2022-01-06
K213839	DePuy Corail AMT Hip Prosthesis	Depuy Orthopaedics Inc.	LZO	Class II	2022-01-06
K213546	ExactechGPS Total Shoulder Application, Equinoxe Planning Software	Blue Ortho	OLO	Class II	2022-01-06
K213544	Tomtec-Arena	TOMTEC Imaging Systems GmbH	QIH	Class II	2022-01-06
K213053	Gold Anchor	Naslund Medical Inc.	IYE	Class II	2022-01-06
K212847	Penta Glove	Pentavest Holdings Sdn Bhd	LZA	Class I	2022-01-06
K212797	iPrime Viscodelivery System	Glaukos Corporation	MRH	Class II	2022-01-06