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 358 of 3528

510(k) clearances, page 358 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K202824	BRS Procedure Face Mask	Blackbriar Regulatory Services, LLC	FXX	Class II	2021-03-25
K202133	Disposable Medical Mask	Hangzhou Qianzhiya Sanitary Products Co.,Ltd	FXX	Class II	2021-03-25
K202083	Biodegradable Powder Free Nitrile Examination Glove, Blue-White Color with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs	Shen Wei (USA), Inc.	LZA	Class I	2021-03-25
K202073	NeedleSmart Professional (NS Pro)	Needlesmart Limited	MTV	Class II	2021-03-25
K201982	Air compression therapy system FO-3001; Air compression therapy system FO-3008	Foshan Hongfeng Co.,Ltd	IRP	Class II	2021-03-25
K201878	St-Z5	Z-Systems AG	KCT	Class II	2021-03-25
K201376	ANAM Test System	Vista Lifesciences, Inc.	POM	Class II	2021-03-25
K200177	Low-frequency Multi-function physiotherapy instrument	Shenzhen Kentro Medical Electronics Co., Ltd	NUH	Class II	2021-03-25
K210498	Betta Link Knotless Implant System	T.A.G. Medical Products Corporation Ltd	MBI	Class II	2021-03-24
K203703	I-Q View	First Source Inc	MQB	Class II	2021-03-24
K203560	STERIZONE VP4 Test Pack	Tso3 Inc., Now A Part of Stryker	FRC	Class II	2021-03-24
K203225	Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System	Canon Medical Systems Corporation	JAK	Class II	2021-03-24
K203133	ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube	Envizion Medical, Ltd.	KNT	Class II	2021-03-24
K202650	Medical disposable face mask non sterile	Guangdong Zhong Ling Industrial Group Co., Ltd.	FXX	Class II	2021-03-24
K202453	SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card	Safecare Biotech(hangzhou)co.,Ltd	NFT	Class II	2021-03-24
K202080	Biodegradable Powder Free Nitroprene Examination Glove, Low Dermatitis Potential Claim, Teal-Black Color	Shen Wei (USA), Inc.	LZA	Class I	2021-03-24
K202015	White ENDOSEAL MTA	Maruchi	KIF	Class II	2021-03-24
K201626	Safety Subcutaneous Infusion Set	Epic Medical Pte., Ltd.	FPA	Class II	2021-03-24
K210828	DIOnavi-Denture02	Dio Corporation	EBI	Class II	2021-03-23
K210555	7D Surgical System - Drill Guide	7D Surgical, Inc.	OLO	Class II	2021-03-23
K210325	APOLLO Anterior Cervical Plate (ACP) System	Aurora Spine, Inc.	KWQ	Class II	2021-03-23
K210209	Viz ICH	Viz. Ai, Inc.	QAS	Class II	2021-03-23
K203780	Harvester SI: Sacroiliac Fixation System	Spinus International, Inc.	OUR	Class II	2021-03-23
K203620	Aneroid Sphygmomanometer	Wuxi Exanovo Medical Instrument Co., Ltd.	DXQ	Class II	2021-03-23
K203592	Tigertriever and Tigertriever 17 Revascularization Devce	Rapid Medical Inc.	NRY	Class II	2021-03-23
K203391	TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	IYN	Class II	2021-03-23
K203205	Navigated Spine Instruments	Howmedica Osteonics Corp	OLO	Class II	2021-03-23
K203064	ICU Health Surgical Mask	Plastikon Industries	FXX	Class II	2021-03-23
K202917	LigaSure Exact Dissector, Nano-coated	Medtronic, Inc.	GEI	Class II	2021-03-23
K202483	MyHomeDoc	Myhomedoc, Ltd.	DQD	Class II	2021-03-23
K202186	TrueRelief Device	Truerelief	GZJ	Class II	2021-03-23
K203737	Spark Clear Aligner System	Ormco Corporation	NXC	Class II	2021-03-22
K203612	Capture-CMV	Immucor, Inc.	LJO	Class II	2021-03-22
K203296	Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit	Gold Standard Diagnostics, LLC	LSR	Class II	2021-03-22
K203295	Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit	Gold Standard Diagnostics, LLC	LSR	Class II	2021-03-22
K203292	Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit	Gold Standard Diagnostics, LLC	LSR	Class II	2021-03-22
K203289	Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit	Gold Standard Diagnostics, LLC	LSR	Class II	2021-03-22
K202492	EZ-IO Intraosseous Vascular Access System	Teleflex Medical	FMI	Class II	2021-03-22
K202009	Probe Cover: JZ-KBT-001, JZ-KBT-002, JZ-KBT-005, JZ-KBT-007, JZ-KBT-008, JZ-KBT-009, JZ-KBT-010, JZ-KBT-015, JZ-KBT-025, JZ-KBT-026	Shenzhen Juzhong Technology Co.,Ltd	FLL	Class II	2021-03-22
K203052	Movement and Compressions System (the MAC System)	Recovery Force, LLC	JOW	Class II	2021-03-21
K210479	IMPACT and X-Ranger	Minxray Inc	IZL	Class II	2021-03-19
K210472	SPINEART Navigation Instrument System	Spineart SA	OLO	Class II	2021-03-19
K210125	BonOs HV Genta, BonOs MV Genta, BonOs LV Genta	Osartis GmbH	LOD	Class II	2021-03-19
K210120	BonOs HV, BonOs MV, BonOs LV	Osartis GmbH	LOD	Class II	2021-03-19
K203593	Patient Examination Gloves	Guangdong Kingfa Sci.&tech.co.,Ltd.	LZA	Class I	2021-03-19
K203235	VBrain	Vysioneer, Inc.	QKB	Class II	2021-03-19
K203116	SensorX	Durr Dental SE	MUH	Class II	2021-03-19
K202985	LightWalker Laser System Family	Fotona d.o.o.	GEX	Class II	2021-03-19
K202628	Disposable Medical Face Mask	Qinghai Zhong Dao Win-Win Medical Protective Equipment Co.	FXX	Class II	2021-03-19
K202379	Invacare AVIVA Storm RX Power Chair	Invacare GmbH	ITI	Class II	2021-03-19