Isolette Infant Incubator

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K960980 ↗

FDA Product Code

FMZ

Device Class

Class II

Regulation

21 CFR Part 880.5400

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K875270 Active Cleared 19 Jan 1988

• Watchchild Obsterical Patient Data Management System

  Class II

  FDA 510(k) K974248 Active Cleared 7 Oct 1998

• Isolette Incubator

  Class II

  FDA 510(k) K781876 Active Cleared 7 Dec 1978

• Duo-Lite Phototherapy System

  Class II

  FDA 510(k) K971256 Active Cleared 24 Sep 1997

• Monitoring System AS100-AS115 Record

  Class I

  FDA 510(k) K832754 Active Cleared 22 Dec 1983

• Rw Resucitaire Infant Radiant Warmer

  Class II

  FDA 510(k) K940951 Active Cleared 3 May 1995

See all devices from Air-Shields, Inc. →

• What is the primary purpose of the Isolette Infant Incubator?

  The Isolette Infant Incubator is designed to create a controlled thermal-neutral environment for low birth weight or preterm infants who struggle with thermoregulation. By maintaining stable temperature and humidity levels, it mimics the protective conditions of the womb, reducing energy expenditure and supporting physiological stability in vulnerable newborns during critical early development.

• How is the Isolette Infant Incubator supplied and prepared for use?

  The Isolette Infant Incubator is supplied as a reusable medical device. Between uses, it requires thorough cleaning and maintenance to ensure sterility and proper functionality. Proper disinfection protocols must be followed to prevent cross-contamination and maintain device integrity for subsequent patient care.

• Are there different models available for the Isolette Infant Incubator?

  Yes, the Isolette Infant Incubator is available in multiple configurations, including the C100 and C200 series. These models are tailored for neonatal use, though specific variations in features or specifications are not detailed in regulatory records. The choice of model may depend on clinical needs, such as incubator size or advanced monitoring capabilities.

• Can the Isolette Infant Incubator be used outside of neonatal care units?

  The device is specifically intended for use in general hospital settings, particularly neonatal care units. While its design supports critical neonatal care, its regulatory classification and intended use are focused on environments where preterm or sick infants require controlled thermal environments. Use in other settings would require validation of safety and efficacy for those specific applications.

• What regulatory pathway does the Isolette Infant Incubator follow?

  The Isolette Infant Incubator has undergone a Traditional 510(k) clearance process through the FDA, confirming its substantial equivalence to a predicate device. This pathway ensures that the device meets established safety and performance standards for neonatal incubators. The device is classified under FDA regulation number 880.5400, reflecting its classification as a Class II medical device.