Uni-Vent Impact Minute Volume Ventilator

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Uni-Vent(Tm) Impact Minute Volume Ventilator

510(k) Number

K870861 ↗

FDA Product Code

CBK

Device Class

Class II

Regulation

21 CFR Part 868.5895

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Impact, Models 306/307

  Class II

  FDA 510(k) K820338 Active Cleared 2 Mar 1982

• Impact Model E-12

  Class II

  FDA 510(k) K820330 Active Cleared 23 Feb 1982

• Impact Model 308

  Class II

  FDA 510(k) K841538 Active Cleared 11 Jun 1984

• Impact Model 753

  Class II

  FDA 510(k) K931473 Active Cleared 30 Dec 1994

• Impact 901 Series Port-a-Wall

  Class I

  FDA 510(k) K850671 Active Cleared 11 Mar 1985

• Impact, Universal Single-Limb, Ventilator Circuit, Model 820-0099-00

  Class II

  FDA 510(k) K022062 Active Cleared 6 May 2003

See all devices from Impact Instrumentation, Inc. →

• What clinical environments is the Uni-Vent Impact Minute Volume Ventilator intended for use in, and why is it not suitable for home or portable settings?

  The Uni-Vent Impact Minute Volume Ventilator is designed specifically for facility-based applications in anesthesia and critical care environments where consistent, controlled ventilation is required. It is classified as a reusable Class II device and is not intended for single-use or home settings. The device’s regulatory route—FDA 510(k) clearance under the Anesthesiology advisory committee—reflects its classification for institutional use only, ensuring compliance with standards for continuous, monitored ventilation in controlled clinical settings.

• How is the Uni-Vent Impact Minute Volume Ventilator supplied, and what does this mean for its maintenance and reuse?

  The Uni-Vent Impact Minute Volume Ventilator is supplied as a reusable medical device, meaning it is intended for repeated use within a facility after proper cleaning, disinfection, and maintenance. This design eliminates the need for single-use consumables, reducing waste and costs over time. However, it requires adherence to facility protocols for sterilization and upkeep to ensure patient safety and device longevity.

• Are there any specific storage requirements for the Uni-Vent Impact Minute Volume Ventilator, and how should it be handled to maintain functionality?

  While the provided data does not explicitly detail storage conditions, as a reusable facility-use ventilator, it should be stored in a clean, dry environment protected from dust, moisture, and extreme temperatures. Proper handling includes avoiding exposure to contaminants or physical damage, as these factors could compromise performance or require additional maintenance before reuse.

• What regulatory pathway was followed for FDA clearance of the Uni-Vent Impact Minute Volume Ventilator, and what does this indicate about its intended use?

  The Uni-Vent Impact Minute Volume Ventilator received FDA 510(k) clearance under the Anesthesiology advisory committee (AN) on January 19, 1988, with a decision code of *Substantially Equivalent* (SESE). This clearance route confirms the device meets regulatory standards for continuous-use ventilators in facility settings, specifically for anesthesia and critical care. The classification as a Class II device further supports its use in controlled clinical environments where precise ventilation is critical.