# K132543: Infant Incubator

- Pathway: 510(k) (Traditional)
- Applicant: Bistos Co., Ltd.
- Decided: Jul 3, 2014 after 324 days
- Product code: FMZ (Incubator, Neonatal)
- Device class: 2
- Regulation: 21 CFR 880.5400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K962603 (1997). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102710: Neo-Servo I, Atom Medical Corporation (2010) Summary page 1.

## Indications for use
Bisto's BT-500 is a Infant Incubator and intended to keep Premature neonate infants in a warm environment in the hood for Neonatal hypothermia. Observation and Examination in newborn nurseries. BT-500 provides Heat and Air in a controlled manner to neonates or premature infants who are unable to thermo-regulate on their own physiology. BT-500 is not intended for transport.

Source page: https://510kreport.com/device/K132543
Methodology: https://510kreport.com/methodology