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Atom Transcapsule V-707

FDA 510(k)

Class II (US FDA 510(k))

510(k) K123937

by Atom Medical Corporation

Identifiers

510(k) Number
K123937 FDA 510(k)
FDA Product Code
FPL FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5410 FDA 510(k)
Regulation Number
880.5410 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Atom Transcapsule V-707 is a closed-type neonatal transport incubator designed for transporting low birth weight infants and seriously ill neonates. Classified as a neonatal transport device, it provides a controlled environment to maintain thermal regulation, humidity, and oxygen levels during transport between healthcare settings.

This device is intended for single-use or reusable applications in general hospital settings, as specified by regulatory submissions. Supplied sterile or non-sterile based on clinical protocol, it adheres to FDA 510(k) clearance (K123937) under traditional review. The V-707 is categorized under product code FPL and regulation number 880.5410, with electromagnetic compatibility considerations noted in service documentation.

Frequently asked questions

What types of neonatal patients is the Atom Transcapsule V-707 specifically designed to transport?

The Atom Transcapsule V-707 is designed for transporting low birth weight infants and seriously ill neonates. Its controlled environment helps maintain thermal regulation, humidity, and oxygen levels during transport between healthcare settings, ensuring stability for vulnerable patients.

Is the Atom Transcapsule V-707 intended for single-use or reusable applications, and how should sterility be handled?

The V-707 is approved for both single-use and reusable applications in general hospital settings. Sterility depends on clinical protocol—it can be supplied sterile or non-sterile, so facilities should follow their infection control guidelines to determine the appropriate handling and reprocessing procedures.

What regulatory pathway was followed for FDA clearance of the Atom Transcapsule V-707, and what does that mean for its use?

The V-707 received FDA clearance under a traditional 510(k) review (K123937) and was determined to be substantially equivalent to a predicate device. This means it was evaluated for safety and effectiveness based on comparative data, and its use is authorized for neonatal transport in general hospital settings as classified under product code FPL and regulation 880.5410.

Are there specific size or model variations available for the Atom Transcapsule V-707, or is it a single standardized unit?

The provided data does not specify multiple size or model variations for the V-707. It is described as a single closed-type neonatal transport incubator, implying a standardized design for general hospital use. For exact specifications (e.g., dimensions, capacity), refer to the manufacturer’s technical documentation.

How should the Atom Transcapsule V-707 be stored, and are there any special considerations for its transport environment?

While storage instructions aren’t detailed in the data, the V-707 is designed for transporting neonates, so it must be stored in a way that maintains its functionality for emergency use. Facilities should ensure it is kept in a clean, dry environment and protected from physical damage. Additionally, since it regulates temperature, humidity, and oxygen, storage conditions should not compromise its ability to perform these functions when deployed.

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 Transcapsule V-707 Service Manual | PDF | Electromagnetic ... - Scribd, PDF Atom Transcapsule - Frank's Hospital Workshop, Atom Medical - V-707 Manuals and Documents | Medical - MedWrench, Atom Medical V-707 TranscapsuleIncubator - MedWrench

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) K123937 24 fields · synced Sep 18, 2026