Model 780

• • Ongoing Z-2991-2026 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.

• • Terminated Z-2107-2014 FDA Class II ·initiated 9 Jul 2014

  The temperature probe does not properly connect to the temperature port.

• • Terminated Z-0419-2016 FDA Class II ·initiated 17 Apr 2014

  Product is being recalled due to complaints that the inspiratory and expiratory tubes are transposed.

510(k) Number

K031383 ↗

FDA Product Code

BTT

Device Class

Class II

Regulation

21 CFR Part 868.5450

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K923946 Active Cleared 18 Oct 1994

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  FDA 510(k) K010402 Active Cleared 14 Mar 2001

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  Class II

  FDA 510(k) K994352 Active Cleared 22 Mar 2000

• Oxygen Supply Tubing, Model 1115

  Class I

  FDA 510(k) K011134 Active Cleared 13 Jun 2001

See all devices from Hudson Respiratory Care, Inc. →