# K941106: Model TI500 Isolette Infant Incubator

- Pathway: 510(k) (Traditional)
- Applicant: Air-Shields, Inc.
- Decided: Jun 10, 1994 after 95 days
- Product code: FPL (Incubator, Neonatal Transport)
- Device class: 2
- Regulation: 21 CFR 880.5410
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 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
- K123937: Atom Transcapsule  V-707 (2013), 0 descendants of its own
- K081264: Statstrap Neonatal Incubator Safety Strap, Models SS-001, SS-002 (2009), 0 descendants of its own
- K061071: V-808 Atom Transcapsule (2006), 0 descendants of its own

## Recalls of this device
- Jan 31, 2008 · Not classified · Z-1051-2008: Heating failure- The power board which controls the incubator heater may not regulate the temperature properly resulting in a high temperature alarm and a loss of temperature control within the patien

Source page: https://510kreport.com/device/K941106
Methodology: https://510kreport.com/methodology