Neonatal Ventilator Circuit

• • Ongoing Z-2992-2026 FDA Class II ·initiated 13 Jul 2026

  Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage. Device failure may predispose infant to bronchospasm, inspissated secretions, and airway obstruction, as well as inadvertent positive end-expiratory pressure (PEEP), circuit obstruction, or accidental lavage of pooled fluid into the airway, elevated oxygen consumption, and worsening respiratory distress.

510(k) Number

K903083 ↗

FDA Product Code

BZO

Device Class

Class I

Regulation

21 CFR Part 868.5975

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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