# K070291: Medix Natal Care Intensive Care Incubator, Models-Natal Care ST-MX/LX/BX

- Pathway: 510(k) (Traditional)
- Applicant: Medix I.C.S.A.
- Decided: Sep 21, 2007 after 234 days
- Product code: FMZ (Incubator, Neonatal)
- Device class: 2
- Regulation: 21 CFR 880.5400
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K920049 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920049: Medix PC-305 Neonatal Incubator, Medix I.C.S.A. (1993) Summary page 1.
- K001242: Isolette Infant Incubator, Model C2HS, Hill-Rom Air-Shields (2000) Summary page 1.

## Recalls of this device
- Aug 25, 2016 · Class II · Z-0056-2017: 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.
- Jan 8, 2016 · Class II · Z-1363-2016: 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 detachin

## Indications for use
The Medix Natal Care ST-MX/LX/BX Intensive Care Incubator provides a controlled thermal environment for neonates who are unable to provide their own thermoregulation. The Medix Natal Care ST-MX/LX/BX Intensive Care Incubator can be used in two operating modes: Air Control Mode and Skin Control Mode with two probes that can be used with twins or for a follow up of central/peripheral temperature variations in a patient as a tool for the early detection of thermal stress-effect on the newborn.

Source page: https://510kreport.com/device/K070291
Methodology: https://510kreport.com/methodology