# K960980: Isolette Infant Incubator

- Pathway: 510(k) (Traditional)
- Applicant: Air-Shields, Inc.
- Decided: Jul 30, 1996 after 141 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
No predicates in its family tree.
5 later devices descend from it; 4 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K971366: Incuwarmer (1998), 2 descendants of its own
- K993051: Versalet 7700 Care Center, Model # 7700 (2000), 1 descendant of its own
- K071977: Tarry Medical Temperature Probes (2008), 0 descendants of its own
- K053399: Versalet 7700 Care Center (2006), 0 descendants of its own
- K031387: Isolette Infant Incubator, Model C2000E (2003), 0 descendants of its own

Source page: https://510kreport.com/device/K960980
Methodology: https://510kreport.com/methodology