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IVent 201 Portable Ventilator

by Versamed, Ltd. 2 variants

510(k) K021981

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK021981 Date13 Aug 2003ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
NOU
FDA applicant
Versamed , Ltd.
Device Class
Class II
Regulation
21 CFR Part 868.5895
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

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

The IVent 201 Portable Ventilator is a continuous, microprocessor-controlled device designed for home use. It functions as a turbine-powered system that provides respiratory support in a compact, portable design.

This device is authorized under FDA 510(k) clearance. It features an internal rechargeable battery and is intended for use in various clinical or home settings as a mechanical ventilator.

Other devices from Versamed, Ltd.

Questions

AI-generated answers, 24 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 primary function of the IVent 201 Portable Ventilator?

    The IVent 201 is a continuous, microprocessor-controlled mechanical ventilator. It utilizes a turbine-powered system to provide necessary respiratory support for patients.

  • Where can the IVent 201 be used?

    This device is intended for use in both home and clinical settings. Its compact, portable design and internal rechargeable battery allow for flexibility in various care environments.

  • What is the regulatory status of this device?

    The IVent 201 Portable Ventilator is authorized under FDA 510(k) clearance. It is classified as a Class 2 medical device under regulation number 868.5895.