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Medix Natal Care Intensive Care Incubator, Models-Natal Care St-Mx/Lx/Bx

by Medix I.C.S.A.

510(k) K070291

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK070291 Date21 Sep 2007ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0056-2017 FDA Class II initiated 25 Aug 2016

    NatalCare LX incubators may have a defective base where the weld holding the wheel bushing to the tube is inadequate. There were several complaints of wheels bending out of alignment.

    • Terminated Z-1363-2016 FDA Class II initiated 8 Jan 2016

    NatalCare LX Incubators were manufactured using a defective oval port hinge assembly with the result that the screws holding the port in place can become loose and possibly result in the port detaching from the incubator.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FMZ
Device Class
Class II
Regulation
21 CFR Part 880.5400
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Medix Natal Care Intensive Care Incubator, Models ST-MX/LX/BX, is a neonatal incubator designed to maintain a controlled thermal environment for premature or critically ill newborns who cannot regulate their own body temperature. Classified as a neonatal incubator, it provides isolation and a stable thermal space essential for long-term neonatal care in intensive settings. The device supports critical physiological stability while minimizing environmental stressors for vulnerable infants.

This incubator is supplied as a reusable medical device intended for use in general hospital neonatal intensive care units. It is not sterile upon delivery and requires cleaning and disinfection between uses. The device is classified under FDA regulation 880.5400 and holds a Traditional 510(k) clearance (K070291) as substantially equivalent to a predicate device. Models ST-MX, LX, and BX are available, with specifications and configurations detailed in the manufacturer’s documentation.

Other devices from Medix I.C.S.A.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Medix Natal Care Intensive Care Incubator used for?

    The Medix Natal Care Intensive Care Incubator (Models ST-MX, LX, and BX) is designed specifically for premature or critically ill newborns who cannot regulate their own body temperature. It creates a controlled thermal environment to maintain physiological stability, reduce environmental stressors, and support long-term care in neonatal intensive care units (NICUs). The device ensures isolation while providing a stable thermal space, which is critical for vulnerable infants requiring intensive medical attention.

  • How is the Medix Natal Care Intensive Care Incubator supplied and prepared for use?

    The incubator is supplied as a reusable medical device and is not sterile upon delivery. Before use, it must be thoroughly cleaned and disinfected to ensure hygiene and safety for each newborn patient. The manufacturer provides detailed instructions for proper maintenance and disinfection procedures to comply with clinical standards and ensure optimal performance.

  • Are the ST-MX, LX, and BX models interchangeable, or do they have distinct features?

    The ST-MX, LX, and BX models are distinct configurations of the Medix Natal Care Intensive Care Incubator, each offering specific design or functional variations. While the core purpose remains the same—providing a controlled thermal environment for neonatal care—the exact specifications, such as size, features, or operational capabilities, differ between models. The manufacturer’s documentation outlines the unique attributes of each model to help clinicians select the appropriate unit for their clinical needs.

  • How should the Medix Natal Care Intensive Care Incubator be stored when not in use?

    The incubator should be stored in a clean, dry, and well-ventilated environment to prevent damage or contamination. It should be kept in its original packaging or a designated storage area away from direct sunlight, extreme temperatures, and sources of moisture. Regular maintenance, including cleaning and disinfection, should be performed as part of the storage routine to ensure the device remains ready for use when needed.

  • What regulatory pathway does the Medix Natal Care Intensive Care Incubator follow?

    The Medix Natal Care Intensive Care Incubator holds a Traditional 510(k) clearance (K070291) from the FDA, classified under regulation 880.5400. This clearance confirms that the device is substantially equivalent to a predicate device and meets the necessary safety and performance standards for use in general hospital settings, specifically neonatal intensive care units. The device is also registered with the FDA under the product code FMZ.