Therma-Shield Neonatal Incubator

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

Full name

Therma-Shield

510(k) Number

K801461 ↗

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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• What types of neonatal patients is the Therma-Shield designed to support in a hospital setting?

  The Therma-Shield is specifically designed to provide a controlled thermal and environmental environment for premature or low-birth-weight infants. Its features—including stable temperature, humidity, and oxygen regulation—are intended to support physiological stability during critical early development stages in neonatal intensive care units (NICUs) or general hospital wards.

• Is the Therma-Shield intended for single-use or reusable applications, and how does this affect maintenance?

  The Therma-Shield is supplied as a reusable, non-sterile medical device. Because it is not single-use, proper cleaning, maintenance, and storage per the manufacturer’s guidelines are essential to preserve its functionality and ensure safe, repeated use in neonatal care settings.

• What regulatory pathway was followed for FDA clearance of the Therma-Shield, and what does this mean for its use?

  The Therma-Shield received FDA clearance through a 510(k) submission (K801461) under the Traditional clearance type, classified as substantially equivalent to a predicate device. This means it was evaluated for safety and effectiveness compared to an existing, legally marketed device and is authorized for use in general hospital settings, including NICUs, as described in its regulatory filing.

• Are there any special storage or handling requirements for the Therma-Shield beyond standard maintenance?

  While the device itself is non-sterile and reusable, the manufacturer provides specific guidelines for storage and maintenance to ensure its proper function. These instructions should be followed to avoid degradation of performance, though no additional MRI safety restrictions are noted in the regulatory filings.