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Venturi Ventilator Modification

by Cardiopulmonary Corp.

510(k) K990429

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)ST Special NumberK990429 Date24 Feb 1999DecidedStatusActive

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  • Withdrawn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)

Full name
Modification of Venturi Ventilator
510(k) Number
FDA Product Code
CBK
Device Class
Class II
Regulation
21 CFR Part 868.5895
Advisory Committee
Anesthesiology
FDA Decision
ST

Overview

AI-generated summary, 19 Sep 2026

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

This device is a Venturi Ventilator, a continuous-use mechanical ventilator designed for facility deployment. It delivers controlled ventilation to patients by adjusting gas flow and oxygen concentration, primarily used in critical care settings such as intensive care units (ICUs).

The Venturi Ventilator Modification is intended for facility use and has been cleared under the FDA 510(k) pathway (K990429) as a Class 2 Anesthesiology device (product code CBK). It is not classified as single-use or reusable in the provided data, and no MRI safety or sterility specifications are noted. The device is regulated under 21 CFR 868.5895 and is subject to special review tracking.

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