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Incu I

FDA 510(k)

Class II (US FDA 510(k))

510(k) K102279

by Atom Medical Corporation

Identifiers

510(k) Number
K102279 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 Incu I is a neonatal incubator, classified as a Class II medical device. It is designed to provide a controlled environment for the care of newborn infants, particularly those requiring intensive support, by maintaining optimal temperature, humidity, and oxygen levels to support physiological stability and growth.

This device is intended for use in neonatal intensive care units (NICU) and obstetric care settings. Supplied as a reusable medical device, the Incu I is not sterile at time of delivery and must be cleaned and disinfected between uses. It is not MRI-compatible and is available in a single configuration as specified by the manufacturer. Regulatory clearance for the Incu I has been granted under the FDA’s 510(k) pathway, with a decision code of SESE (Substantially Equivalent) under the General Hospital advisory committee classification.

Frequently asked questions

Is the Incu I incubator designed for single-use or can it be reused after cleaning and disinfection?

The Incu I is supplied as a reusable medical device and must be cleaned and disinfected between uses. It is not sterile at the time of delivery, so proper decontamination is required before each subsequent use.

What types of clinical environments is the Incu I intended for, and what specific patient needs does it address?

The Incu I is specifically designed for neonatal intensive care units (NICU) and obstetric care settings. It provides a controlled environment to support newborn infants, particularly those requiring intensive support, by maintaining optimal temperature, humidity, and oxygen levels to promote physiological stability and growth.

How is the Incu I incubator regulated, and what does the FDA’s 510(k) clearance indicate about its equivalence?

The Incu I received FDA clearance through the 510(k) pathway, classified as substantially equivalent (SESE) under the General Hospital advisory committee. This means the device meets the same performance criteria as a legally marketed predicate device, ensuring it is safe and effective for its intended use in neonatal care.

Does the Incu I come in multiple sizes or configurations, or is it available in a single fixed model?

The Incu I is available in a single configuration as specified by the manufacturer, meaning there is no variability in size or design options—it is supplied uniformly for neonatal use.

Can the Incu I be used in an MRI environment, or are there any compatibility concerns?

The Incu I is explicitly noted as not MRI-compatible, so it should not be used in magnetic resonance imaging environments to avoid potential interference or safety risks.

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: Incubator Incu i | ATOM MEDICAL, Incubator Dual Incu i | ATOM MEDICAL, ATOM Medical USA | Model 101 Incu i Incubator, ATOM Medical USA | Model 100 Dual Incu i Combination Incubator

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) K102279 24 fields · synced Sep 18, 2026