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Critiflo & Critiflo Dome

by Gould, Inc.

510(k) K791844

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

7 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 NumberK791844 Date2 Oct 1979ClearedStatusActive

Recalls

7 recalls · FDA

  • 7 recalls, same reason

    • Terminated Z-0069-06 FDA Unclassified (pre-2012) initiated 1 Jul 2005
    • Terminated Z-0072-06 FDA Unclassified (pre-2012) initiated 1 Jul 2005
    • Terminated Z-0073-06 FDA Unclassified (pre-2012) initiated 1 Jul 2005
    • Terminated Z-0070-06 FDA Unclassified (pre-2012) initiated 1 Jul 2005
    • Terminated Z-0074-06 FDA Unclassified (pre-2012) initiated 1 Jul 2005
    • Terminated Z-0071-06 FDA Unclassified (pre-2012) initiated 1 Jul 2005
    • Terminated Z-0075-06 FDA Unclassified (pre-2012) initiated 1 Jul 2005

    Device could permit an over-infusion of IV solutions during pressure monitoring procedures.

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  • Withdrawn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
KRA
Device Class
Class II
Regulation
21 CFR Part 870.1210
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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