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Infa Warmer I

FDA 510(k)

Class II (US FDA 510(k))

510(k) K102227

by Atom Medical Corporation

Identifiers

510(k) Number
K102227 FDA 510(k)
FDA Product Code
FMT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5130 FDA 510(k)
Regulation Number
880.5130 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Infa Warmer I is an infant radiant warmer, a Class II medical device designed to maintain neonatal body temperature through radiant heat. It provides controlled thermal support to newborns, particularly those at risk of hypothermia, including preterm or low-birth-weight infants during resuscitation, transport, or routine care in labor and delivery or neonatal intensive care units (NICU).

This device is supplied as a reusable medical instrument, featuring a swivel heater head and adjustable handle for mobility. It operates in clinical settings such as general hospitals and is intended for single-patient use per procedure. The Infa Warmer I complies with FDA 510(k) clearance under the Traditional pathway, with a decision date of January 21, 2011, and is regulated under the classification FMT (Infant Radiant Warmer). Sterility is not specified, and MRI safety data is not provided.

Frequently asked questions

Is the Infa Warmer I designed for single-use or reusable in clinical settings, and how does this affect its use in neonatal care?

The Infa Warmer I is explicitly designed as a reusable medical device, meaning it is intended for multiple uses across different patients. However, it is specified for single-patient use per procedure, which clarifies that while the device itself can be reused, it should not be shared between patients during overlapping procedures. This design ensures hygiene and safety in neonatal care, particularly for preterm or low-birth-weight infants requiring controlled thermal support during resuscitation, transport, or routine NICU care.

What types of clinical environments is the Infa Warmer I intended for, and does it have any special considerations for setup or mobility?

The Infa Warmer I is intended for use in general hospitals, specifically in labor and delivery units or neonatal intensive care units (NICU). Its swivel heater head and adjustable handle are key features that enhance mobility, allowing clinicians to position the device flexibly around the infant without obstruction. This design is particularly useful for procedures like resuscitation or transport where space and accessibility are critical.

How does the regulatory pathway for the Infa Warmer I differ from other infant radiant warmers, and what does this imply for its use?

The Infa Warmer I follows the FDA 510(k) Traditional pathway, with a decision date of January 21, 2011, and is classified under product code FMT (Infant Radiant Warmer). This pathway confirms it is substantially equivalent to a predicate device already on the market, meaning its safety and performance meet established standards. Clinically, this implies the device has undergone rigorous review for thermal control safety, reliability, and compliance with neonatal care protocols, ensuring it can be trusted for maintaining infant body temperature in high-risk scenarios.

Does the Infa Warmer I require any special handling or storage conditions, particularly regarding sterility or maintenance?

The device is not specified as sterile, meaning it is not pre-sterilized for single-use applications. As a reusable instrument, it must be properly cleaned, disinfected, and maintained between uses to prevent contamination. Clinicians should follow hospital protocols for reprocessing reusable medical devices, including thorough cleaning and sterilization (if applicable) to ensure safe, repeated use in neonatal care. No specific storage conditions are mentioned beyond standard medical device storage practices.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ATOM Medical USA | Model 103 Infa Warmer i, Infa Warmer i | Product | ATOM MEDICAL, ATOM INFA WARMER I OPERATION MANUAL Pdf Download, ATOM Medical USA | Atom Products

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Atom Medical Corporation

Sources (1)

  • FDA 510(k) K102227 24 fields · synced Sep 18, 2026