Skip to content

Model LTV 1100 Ventilator

by Care Fusion

510(k) K101643

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 NumberK101643 Date26 Jan 2011ClearedStatusActive

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  • Withdrawn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, 22 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 Model LTV 1100 Ventilator is a continuous, facility-use ventilator classified as a Class II medical device. It is designed for ventilatory support in clinical settings and is substantially equivalent to predicate devices cleared under the FDA 510(k) process.

The device is supplied as a reusable system for use in healthcare facilities. It has received FDA 510(k) clearance (K101643) and is regulated under regulation number 868.5895. The ventilator is intended for use in anesthesiology and related clinical environments as indicated by its advisory committee classification.

Other devices from Carefusion

See all devices from Carefusion →

Questions

AI-generated answers, 22 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 Model LTV 1100 Ventilator used for?

    The Model LTV 1100 Ventilator is designed for ventilatory support in clinical settings, specifically indicated for use in anesthesiology and related clinical environments as a continuous, facility-use ventilator.

  • Is the Model LTV 1100 Ventilator reusable or single-use?

    The Model LTV 1100 Ventilator is supplied as a reusable system for use in healthcare facilities, meaning it is intended for repeated use after appropriate cleaning and disinfection between patients.

  • What regulatory clearance does the Model LTV 1100 Ventilator have?

    The Model LTV 1100 Ventilator has received FDA 510(k) clearance under K101643 and is classified as a Class II medical device under regulation number 868.5895, determined to be substantially equivalent to predicate devices.