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Modification to Ltv 1000 Ventilator

by Pulmonetic Systems, Inc.

510(k) K040540

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

8 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 · Special NumberK040540 Date29 Apr 2004ClearedStatusActive

Recalls

8 recalls · FDA

  • 8 recalls, same reason

    • Terminated Z-1466-2008 FDA Unclassified (pre-2012) initiated 22 Feb 2008
    • Terminated Z-1470-2008 FDA Unclassified (pre-2012) initiated 22 Feb 2008
    • Terminated Z-1465-2008 FDA Unclassified (pre-2012) initiated 22 Feb 2008
    • Terminated Z-1467-2008 FDA Unclassified (pre-2012) initiated 22 Feb 2008
    • Terminated Z-1463-2008 FDA Unclassified (pre-2012) initiated 22 Feb 2008
    • Terminated Z-1464-2008 FDA Unclassified (pre-2012) initiated 22 Feb 2008
    • Terminated Z-1469-2008 FDA Unclassified (pre-2012) initiated 22 Feb 2008
    • Terminated Z-1468-2008 FDA Unclassified (pre-2012) initiated 22 Feb 2008

    The failure of an electronic component could result in failure of the ventilator to breathe for the patient and/or failure of the ventilator to properly alarm to alert the caregiver.

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  • Withdrawn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

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