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Ohmeda 7400 Anesthesia Ventilator

by Ohmeda Medical

510(k) K864129

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 NumberK864129 Date16 Dec 1986ClearedStatusActive

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  • Withdrawn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
CBK
Device Class
Class II
Regulation
21 CFR Part 868.5895
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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.

The Ohmeda 7400 Anesthesia Ventilator is a continuous-use, facility-based device classified as a ventilator. It is designed to provide mechanical ventilation support to patients during anesthesia and critical care, ensuring controlled delivery of oxygen and other respiratory gases while monitoring and adjusting respiratory parameters.

This device is intended for use in hospital or clinical settings and is regulated under FDA 510(k) clearance (K864129) as a Class II medical device under product code CBK. It is not specified as single-use or reusable in the provided data, and no MRI safety information is included. The device was cleared in 1986 and remains subject to the regulatory requirements outlined in 21 CFR 868.5895.

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