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Neo-Servo I

FDA 510(k)

Class II (US FDA 510(k))

510(k) K102710

by Atom Medical Corporation

Identifiers

510(k) Number
K102710 FDA 510(k)
FDA Product Code
FMZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5400 FDA 510(k)
Regulation Number
880.5400 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Neo-Servo I Infant Incubator Model 102 is a closed-type neonatal incubator designed for temperature regulation in newborns and premature infants. It supports clinical applications such as hypothermia management, observation and examination in neonatal nurseries, and pre- and post-operative intensive care to maintain stable physiological conditions.

This device is intended for use in general hospital settings and is supplied as a reusable medical instrument. It is classified under FDA regulation 880.5400 as a Class II device, with clearance granted through a Traditional 510(k) pathway. The incubator is not described as sterile or MRI-safe, and its operational specifications—including size, storage, or additional safety features—are not detailed in the provided data.

Frequently asked questions

What clinical settings is the Neo-Servo I Infant Incubator primarily designed for use in, and what specific patient populations does it support?

The Neo-Servo I Infant Incubator is designed for use in general hospital settings, particularly neonatal nurseries and intensive care units. It is specifically intended for newborns and premature infants to maintain stable physiological conditions, including applications like hypothermia management and pre- and post-operative care.

Is the Neo-Servo I Infant Incubator reusable or single-use, and what does this mean for maintenance and cleaning?

The Neo-Servo I Infant Incubator is supplied as a reusable medical instrument. This means it is intended to be cleaned, disinfected, and reused for multiple patients, requiring adherence to proper infection control protocols and maintenance procedures to ensure safety and functionality.

How was the regulatory clearance for the Neo-Servo I Infant Incubator obtained, and what does this indicate about its compliance standards?

The Neo-Servo I Infant Incubator received FDA clearance through a Traditional 510(k) pathway, which means it was determined to be substantially equivalent to a legally marketed device already on the market. This clearance indicates that it meets the regulatory standards for safety and effectiveness as defined by the FDA for Class II medical devices.

What does the product code (FMZ) and classification under FDA regulation 880.5400 imply about the intended use and oversight of this device?

The product code FMZ and classification under FDA regulation 880.5400 categorize the Neo-Servo I Infant Incubator as a neonatal incubator under the General Hospital specialty. This classification indicates it is subject to specific FDA oversight to ensure it meets performance and safety standards for use in neonatal care environments, though it does not define its clinical indications.

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: NEO-SERVO I (K102710) — FDA 510(k) | Innolitics, Product | ATOM MEDICAL, NEO-SERVO I 510 (k) K102710 - FDA.report

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) K102710 24 fields · synced Sep 18, 2026