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Sunflower Warmer

FDA 510(k)

Class II (US FDA 510(k))

510(k) K120937

by Atom Medical Corporation

Identifiers

510(k) Number
K120937 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 Sunflower Warmer is an Infant Radiant Warmer (Device Class II), designed for thermoregulation of newborns and premature neonates. It provides controlled radiant heat to maintain stable body temperature, supports skin temperature monitoring, and facilitates Apgar scoring during neonatal care.

This device is intended for use in hospital or institutional settings and is supplied as a reusable medical instrument. It has received FDA 510(k) clearance (K120937) under the Substantially Equivalent (SESE) determination, adhering to regulatory standards for infant radiant warmers. No specific sterility or MRI safety information is provided in the available data.

Frequently asked questions

What clinical setting is the Sunflower Warmer intended for, and how does it support neonatal care?

The Sunflower Warmer is designed exclusively for use in hospital or institutional settings, such as neonatal intensive care units (NICUs) or maternity wards. It provides controlled radiant heat to maintain stable body temperature in newborns and premature neonates, which is critical for preventing hypothermia—a common risk in vulnerable infants. Additionally, it includes skin temperature monitoring to ensure precise thermoregulation and facilitates Apgar scoring by providing a stable, warm environment during initial assessments.

Is the Sunflower Warmer single-use or reusable, and what does this mean for maintenance and cleaning?

The Sunflower Warmer is supplied as a reusable medical instrument, meaning it is designed for repeated use across multiple patients after proper cleaning, disinfection, and maintenance. Since it is not sterile by default, facilities must follow hospital infection control protocols for reprocessing to ensure safety between uses. Reusability also implies that it requires regular servicing to maintain performance, including calibration of the heating and monitoring systems.

What regulatory pathway was followed for FDA clearance, and how does this affect its use in hospitals?

The Sunflower Warmer received FDA 510(k) clearance (K120937) under a Substantially Equivalent (SESE) determination, meaning it was deemed comparable to a legally marketed predecessor device. This clearance confirms it meets FDA standards for infant radiant warmers (Device Class II) and adheres to regulations under 21 CFR 880.5130. Hospitals can confidently use it as a Class II device, though they must still follow facility-specific protocols for operation, maintenance, and patient monitoring to ensure safe and effective thermoregulation.

Are there specific storage requirements for the Sunflower Warmer to ensure its functionality and safety?

While the provided data does not specify exact storage conditions, as a reusable medical device, the Sunflower Warmer should be stored in a clean, dry environment when not in use to prevent contamination or damage. Facilities should also follow manufacturer guidelines (available from Atom Medical Corporation) for long-term storage, including protection from extreme temperatures or humidity, to maintain its heating and monitoring accuracy. Proper storage is essential for preserving the device’s performance and longevity.

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: Sunflower Warmer | Product | ATOM MEDICAL, ATOM Medical USA | Sunflower Freestanding Warmer, K120937 · SUNFLOWER WARNER · DeviceClearance, SUNFLOWER WARNER (K120937) — FDA 510 (k) | Innolitics, 510 (k) K120937 — SUNFLOWER WARNER — RegDataLab

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) K120937 24 fields · synced Sep 18, 2026