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 337 of 3528

510(k) clearances, page 337 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K201089	ARK Lacosamide Assay	Ark Diagnostics Inc	NWM	Class II	2021-08-05
K200904	Tosoh Automated Glycohemoglobin Analyzer HLC-723G8	Tosoh Bioscience Inc	PDJ	Class II	2021-08-05
K212056	Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR	Canon Medical Systems Corporation	LNH	Class II	2021-08-04
K211838	Ultrasonic Bipolar Generator USG-410 with accessories	Olympus Medical Systems Corp.	LFL	Unclassified	2021-08-04
K211714	Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy)	Hengchang (Dongying) Medical Technology Co., Ltd.	LZA	Class I	2021-08-04
K211553	Tecomet Global Unite Short Stem Instrumentation	Symmetry Medical Manufacturing Inc. dba Tecomet, Inc.	PHX	Class II	2021-08-04
K211502	Alpha Vent PEEK Suture Anchor	Stryker Corp.	MBI	Class II	2021-08-04
K211068	PrevisEA Device	Entac Medical, Inc.	DQD	Class II	2021-08-04
K211049	Tigon Medical Button System	Tigon Medical LLC	MBI	Class II	2021-08-04
K210913	V12 Pro	Slk Medical GmbH	IRP	Class II	2021-08-04
K210643	Disposable Surgical Face Mask	Shandong Zhushi Pharmaceutical Group Co., Ltd	FXX	Class II	2021-08-04
K203464	DESS Dental Smart Solutions	Terrats Medical, S.L.	NHA	Class II	2021-08-04
K203246	Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pregnancy Test (Cassette), Atlas One Step hCG Urine Pregnancy Test (Midstream)	Atlas Link Technology Co., Ltd.	LCX	Class II	2021-08-04
K212144	Remex KA6	Remedi Inc.	IZL	Class II	2021-08-03
K211897	Surgical Face Mask	Zhejiang Hongyu Medicali Commodity Co., Ltd.	FXX	Class II	2021-08-03
K211806	Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter	Venclose, Inc.	GEI	Class II	2021-08-03
K211758	Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour)	Hartalega NGC Sdn Bhd	OPC	Class I	2021-08-03
K211290	Cannulated Fasteners and Nuts	OsteoCentric Technologies,Inc	HWC	Class II	2021-08-03
K211026	Minitube Dentasleeve Protective Barrier Sleeves	Minitube AB	PEM	Class II	2021-08-03
K210724	ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Standard, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs	Careplus (M) Sdn Bhd	KGO	Class I	2021-08-03
K210651	Resection Electrodes with HF cable	Olympus Winter & Ibe GmbH	FAS	Class II	2021-08-03
K201246	PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ)	Qualimed USA, LLC	LIT	Class II	2021-08-03
K212175	DynaCAD	Invivo Corporation	LLZ	Class II	2021-08-02
K212106	Relivion	NEUROLIEF Inc.	PCC	Class II	2021-08-02
K211431	breastscape v1.0	Olea Medical	QIH	Class II	2021-08-02
K210521	DEXA-C Cervical Interbody System	Aurora Spine, Inc.	ODP	Class II	2021-08-02
K210339	Bullfrog Micro-Infusion Device	Mercator Medsystems, Inc.	KRA	Class II	2021-08-02
K203542	Neodent Implant System - Mini Abutment 60°	JJGC Industria e Comercio de Materiais Dentarios SA	NHA	Class II	2021-08-02
K203538	SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs)	MEDLINE INDUSTRIES, LP - Northfield	KGO	Class I	2021-08-02
K203174	Disposable Medical Mask	Dong Guan Kinyet Metal Products Co., Ltd.	FXX	Class II	2021-08-02
K200986	OPTI® B-Lac Cassette	Opti Medical Systems Inc	CHL	Class II	2021-08-02
K211182	H2H Powder Free Examination Blue Glove	Ntl Innovation Co., Ltd.	LZA	Class I	2021-08-01
K212035	FibroScan 230	Echosens	IYO	Class II	2021-07-30
K211790	DX-D Imaging Package with XD Detectors	Agfa N.V.	MQB	Class II	2021-07-30
K211761	UltraLase Flexible CO2 Laser Waveguide	W & R Investments, LLC dba Laser Engineering	GEX	Class II	2021-07-30
K211710	Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation Systems: (Firebird Deformity Spinal Fixation System, Phoenix MIS Spinal Fixation System, Phoenix CDX MIS Spinal Fixation System, JANUS Midline Fixation Screws, Firebird NXG Spinal Fixation System, JANUS Fenestrated Screws), Connector System, FIREBIRD SI Fusion System	Orthofix SRL	NKG	Class II	2021-07-30
K211492	Pounce Thrombectomy System	Surmodics, Inc.	QEW	Class II	2021-07-30
K211402	Powersculp laser lipolysis system	Lotuxs Medtech (Suzhou) Co., Ltd.	PKT	Class II	2021-07-30
K211380	Elexir	NU Eyne Co., Ltd.	PCC	Class II	2021-07-30
K211379	syngo.via RT Image Suite	Siemens Medical Solutions USA, Inc.	MUJ	Class II	2021-07-30
K211338	EMBOTRAP III Revascularization Device	Neuravi Limited	NRY	Class II	2021-07-30
K211264	Disposable Nitrile Examination Gloves	Shenzhen Shiqiao Science and Technology Co., Ltd.	LZA	Class I	2021-07-30
K211222	qER-Quant	Qure.ai Technologies Inc	QIH	Class II	2021-07-30
K210938	PowerDot PD-01MT2 Muscle Stimulator	Smartmissimo Technologies Pte, Ltd.	IPF	Class II	2021-07-30
K210870	MEO Med Disposable Medical Face Mask	Fujian Meo Medical Technology Limited	FXX	Class II	2021-07-30
K210768	Wrist Blood Pressure Monitor, Blood Pressure Monitor	Andon Health Co., Ltd	DXN	Class II	2021-07-30
K210691	Disposable Nitrile Medical Examination Glove	Jiangsu Cureguard Glove Co., Ltd.	LZA	Class I	2021-07-30
K210274	Fingertip Pulse Oximeter	Zhuhai Linte Medical Instrument Co., Ltd.	DQA	Class II	2021-07-30
K210264	BD PowerPiCC Catheter	Bard Access Systems, Inc.	LJS	Class II	2021-07-30
K210248	Lab Bag with Fabric Pouch	Advanced Medical Design Co., Ltd.	GCJ	Class II	2021-07-30