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 313 of 3528

510(k) clearances, page 313 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K210931	Libby IAAA v1.0	Dyad Medical, Inc.	LLZ	Class II	2021-12-17
K210914	Sterile Syringe for Single Use	Jiangsu Suyun Medical Material Co., Ltd.	FMF	Class II	2021-12-17
K210871	PDO Max Suture with Dual Needle	Pdo Max	NEW	Class II	2021-12-17
K210825	Revitive Medic Coach (Model Number 5575AQ)	Actegy Ltd.	NGX	Class II	2021-12-17
K210102	Topwide Surgical Face Mask	Topwide (Hubei) Medical Products Manufacturer	FXX	Class II	2021-12-17
K210077	Med RF 4000	F Care Systems USA	ONQ	Class II	2021-12-17
K203821	Donagamex Blue Performance Protective Gown	Dong Nai Garment Corporation (Donagamex)	QPC	Class II	2021-12-17
K203695	NObreath®	Bedfont Scientific Ltd.	MXA	Class II	2021-12-17
K203424	Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1, Quantum Perfusion Blood Oxygenator ECC VT160-E2	Spectrum Medical Inc	DTZ	Class II	2021-12-17
K200943	Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System	CIRCA Scientific, Inc.	FLL	Class II	2021-12-17
K193081	Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit	Rheonix, Inc.	QEP	Class II	2021-12-17
K213916	ArchForm Orthodontic Software System	Archform, Inc.	PNN	Class II	2021-12-16
K213733	Ponto 5 SuperPower	Oticon Medical AB	LXB	Class II	2021-12-16
K213628	VBrain	Vysioneer, Inc.	QKB	Class II	2021-12-16
K213463	NightOwl	Ectosense NV	MNR	Class II	2021-12-16
K213407	UltiCare Disposable Pen Needles	Ultimed Incorporated	FMI	Class II	2021-12-16
K213020	IPL hair removal machine	Shenzhen Borria Technology Co.,Ltd	OHT	Class II	2021-12-16
K212985	6MP Color LCD Monitor CL-S600	JVCKENWOOD Corporation	PGY	Class II	2021-12-16
K212898	Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With Chemotherapy Drugs	Rimba Glove Snd Bhd	LZA	Class I	2021-12-16
K212645	At	At Glove Engineering Sdn. Bhd	LZA	Class I	2021-12-16
K212630	Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo	Ellex Medical Pty Ltd	HQF	Class II	2021-12-16
K212616	Koios DS	Koios Medical, Inc.	POK	Class II	2021-12-16
K212420	Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio	Brainlab, Inc.	LLZ	Class II	2021-12-16
K212402	MIVI Q Distal Access Catheter	Mivi Neuroscience, Inc.	QJP	Class II	2021-12-16
K212055	Connected OR Hub with Device and Voice Control	Stryker Corp.	GCJ	Class II	2021-12-16
K211471	Balanced Knee System Uni	Ortho Development Corp.	HSX	Class II	2021-12-16
K211378	LM Surgical Mask Level 3, LM Surgical Mask Level 2,	Liberty Mask, LLC	FXX	Class II	2021-12-16
K211277	Theia NPWT Foam Wound Dressing Kit	Clear Choice Therapeutics, Inc.	OMP	Class II	2021-12-16
K211217	Profound Matrix	Candela Corporation	GEI	Class II	2021-12-16
K210355	Surgical Gown, Model: surgical gown-hp-3	Weihai Dishang Medical Technology Co.,Ltd	FYA	Class II	2021-12-16
K202818	Voyant Fine Fusion Device (EB230)	Applied Medical	GEI	Class II	2021-12-16
K202803	Activmotion S DTO	Newclip Technics	HRS	Class II	2021-12-16
K213728	Serranator PTA Serration Balloon Catheter	Cagent Vascular	PNO	Class II	2021-12-15
K213631	Chocolate PTA Balloon Catheter	Medtronic, Inc.	LIT	Class II	2021-12-15
K213443	Insignia™ Anterior Cervical Plate System	Alphatec Spine, Inc.	KWQ	Class II	2021-12-15
K213155	RT-Mind-AI	Medmind Technology Co., Ltd.	QKB	Class II	2021-12-15
K213092	Cellusheet, Cellufil	Human Biosciences, Inc.	KGN	Unclassified	2021-12-15
K212944	Disposable Surgical Mask	Heilongjiang Yinjia Medical Equipment Co., Ltd.	FXX	Class II	2021-12-15
K212919	Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)	Jiujiang Taixin Technology Co., Ltd.	LZA	Class I	2021-12-15
K212903	SIMPACT Sacroiliac Joint Fixation System	Life Spine	OUR	Class II	2021-12-15
K212861	Surgical Gown, Reinforced Surgical Gown	Wuhan Zonsen Medical Products Co., Ltd	FYA	Class II	2021-12-15
K212817	Merit Siege Vascular Plug	Merit Medical System, Inc.	KRD	Class II	2021-12-15
K212781	Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA Minuteman G3 MIS Fusion Plate, HA Minuteman G3-R MIS Fusion Plate	Spinal Simplicity, LLC	PEK	Class II	2021-12-15
K212398	Surgical Face Mask (Non-sterile)	Hubei Kimsoul Industrial Co.,Ltd	FXX	Class II	2021-12-15
K212351	Revolution Peripheral Atherectomy System	Rex Medical LP	MCW	Class II	2021-12-15
K211803	HealthPPT	Zebra Medical Vision, Ltd.	QFM	Class II	2021-12-15
K211539	Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mL	Thermo Fisher Scientific Oy	NGZ	Class II	2021-12-15
K211114	Will3D	HDX Will	LLZ	Class II	2021-12-15
K211039	BIT-Motion	Dde Mri Solutions, Ltd.	LLZ	Class II	2021-12-15
K210965	reVive Light Therapy Essentials	LED Technologies, Inc.	OHS	Class II	2021-12-15