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Bellavista

by Imtmedical AG

510(k) K183364

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

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 NumberK183364 Date13 Sep 2019ClearedStatusActive

Recalls

3 recalls · FDA

  • 2 recalls, same reason

    • Completed Z-1967-2023 FDA Class II initiated 5 May 2023
    • Completed Z-1966-2023 FDA Class II initiated 5 May 2023

    Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bellavista 1000e: 1. Under certain conditions of use, the touchscreen may become unresponsive and the device application stops responding (APP Hang). When this occurs, if the user continues to interact with the touchscreen, a message will appear that states DeviceSoftware.Application is not responding or a decommission screen will appear on the user interface. The ventilator will issue both an audible and visual alarm. Ventilation continues without interruption with the settings applied prior to the APP Hang error. 2. The potential for a use error has been identified if the operator applies the proposed settings without confirming the settings are suitable for the patient.

    • Terminated Z-0622-2022 FDA Class I initiated 20 Dec 2021

    Potential cessation in ventilation can occur under specific conditions.

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  • Withdrawn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, 23 Sep 2026

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

Bellavista is a continuous facility-use ventilator classified as a Class II medical device. It is substantially equivalent to a predicate device and has been reviewed by the Anesthesiology advisory committee.

The device received traditional 510(k) clearance (K183364) from the FDA on September 13, 2019. It is manufactured by Imtmedical AG and is authorized for use in facility settings under the product code CBK and regulation number 868.5895.

Other devices from Imtmedical AG

Questions

AI-generated answers, 23 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 Bellavista ventilator used for?

    The Bellavista is a continuous facility-use ventilator designed for use in facility settings, specifically within anesthesiology applications, as indicated by its product code CBK and medical specialty description.

  • Who manufactures the Bellavista ventilator and where are they located?

    The Bellavista ventilator is manufactured by Imtmedical AG, located at Gewerbestrasse 8, Buchs Sg, 9470, Switzerland (country code CH).

  • What regulatory pathway was used for the Bellavista ventilator and what is its clearance number?

    The Bellavista received traditional 510(k) clearance from the FDA, with clearance number K183364, granted on September 13, 2019, following a determination of substantial equivalence to a predicate device.

  • What class is the Bellavista ventilator and what regulation number applies to it?

    The Bellavista is classified as a Class II medical device under regulation number 868.5895, with product code CBK, as specified in its FDA listing and authorization details.

  • Was the Bellavista ventilator reviewed by an advisory committee, and if so, which one?

    Yes, the Bellavista was reviewed by the Anesthesiology advisory committee (review advisory committee: AN), which evaluated its substantial equivalence during the 510(k) process.