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Babyset and Pac (Pulmonary Assist Circuit)

by Bird Life Design 510(k)

Active United States

510(k) K930252

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK930252 Date9 Feb 1993ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

6 recalls · FDA

  • 6 recalls, same reason

    • Terminated Z-0035-04 FDA Unclassified (pre-2012) initiated 10 Sep 2003
    • Terminated Z-0034-04 FDA Unclassified (pre-2012) initiated 10 Sep 2003
    • Terminated Z-0038-04 FDA Unclassified (pre-2012) initiated 10 Sep 2003
    • Terminated Z-0033-04 FDA Unclassified (pre-2012) initiated 10 Sep 2003
    • Terminated Z-0036-04 FDA Unclassified (pre-2012) initiated 10 Sep 2003
    • Terminated Z-0037-04 FDA Unclassified (pre-2012) initiated 10 Sep 2003

    The exhalation hole in the sideport relief valve may be blocked, allowing excess pressure build-up.

Specification

510(k)

510(k) Number
FDA Product Code
CAI
Device Class
Class I
Regulation
21 CFR Part 868.5240
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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