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eVent Medical, Ltd.

United States·US-MF-000027969

Last updated September 17, 2026

Information

Device	Model / Reference	Registries	Class	Status
Evolution	T	FDA UDI	Class II	Active
eVolution 3e Ventilator	eVolution 3e Ventilator- Turbine Essential	EUDAMEDFDA UDI	Class II	Active
Inspiration 7i Ventilator System	Inspiration Ventilator System	FDA UDI	Class II	Active
Inspiration 7i Ventilator System	Inspiration Ventilator System	FDA UDI	Class II	Active
Inspiration 7i Ventilator System	Inspiration Ventilator System	FDA UDI	Class II	Active
Inspiration Ventilator System	K021112	FDA 510(k)	Class II	Active
Modification To Inspiration Ventilator System	K030341	FDA 510(k)	Class II	Active
Inspiration Ventilator System 5i/7i	K130178	FDA 510(k)	Class II	Active
Medical Air Compressor	K040220	FDA 510(k)	Class II	Active
Evolution 3e Ventilator	K113743	FDA 510(k)	Class II	Active
Inspiration; Ventilator System, Ls Ventilator System, Infant Ventilator System And Infant Ls Ventilator System	K072590	FDA 510(k)	Class II	Active
Inspiration Ventilator System	K051550	FDA 510(k)	Class II	Active
Inspiration	F7300000	EUDAMEDFDA UDI	Class IIb	Active

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Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Oct 13, 2015	Z-0230-2016	—	terminated	A component on the systems power board can fail in a manner which can cause the ventilator to shut down without alarming.
Aug 12, 2005	Z-0062-06	—	terminated	Firm received reports of combustion within the blender system of the Inspiration Ventilator.