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Emergency Portable Ventilator, Model EPV200

by Allied Healthcare Products, Inc.

510(k) K090356

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK090356 Date20 May 2009ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
BTL
Device Class
Class II
Regulation
21 CFR Part 868.5925
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

An emergency portable ventilator is a powered device designed to provide mechanical ventilation for patients requiring respiratory support. The Emergency Portable Ventilator, Model EPV200 is a battery-powered ventilator that requires an external oxygen source and is intended for use with intubated or non-intubated patients.

It is used in emergency and mass casualty settings to support medical surge response. The device is supplied as a reusable unit and is not MRI safe unless explicitly stated. Authorisations include FDA 510(k) clearance under product code BTL and regulation number 868.5925, with device classification as a Class II ventilator for emergency, powered resuscitation use.

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Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the EPV200 ventilator used for?

    The EPV200 is used to provide mechanical ventilation for patients requiring respiratory support in emergency and mass casualty settings.

  • Is the EPV200 ventilator reusable?

    Yes, the EPV200 is supplied as a reusable unit, but it is not MRI safe unless explicitly stated.

  • What are the regulatory authorizations for the EPV200?

    The EPV200 has FDA 510(k) clearance under product code BTL and regulation number 868.5925, classified as a Class II ventilator for emergency, powered resuscitation use.

  • What type of patients can the EPV200 ventilator be used with?

    The EPV200 can be used with both intubated and non-intubated patients, requiring an external oxygen source.