# K001019: TI500 Globe-Trotter Transport System

- Pathway: 510(k) (Traditional)
- Applicant: Hill-Rom Air-Shields
- Decided: Apr 27, 2000 after 28 days
- Product code: FPL (Incubator, Neonatal Transport)
- Device class: 2
- Regulation: 21 CFR 880.5410
- Recalls of this device: 2 (0 Class I)
- 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; 3 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 has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K033565: LMT Nomag IC 1,5 (2003), 2 descendants of its own
- K062052: LMT Nomag IC 3.0 (2006), 1 descendant of its own
- K161918: SREE MRI Transport Incubator (2017), 0 descendants of its own
- K141565: Globe-Trotter GT5400 (2014), 0 descendants of its own
- K081264: Statstrap Neonatal Incubator Safety Strap, Models SS-001, SS-002 (2009), 0 descendants of its own

## Recalls of this device
- Jan 31, 2008 · Not classified · Z-1052-2008: 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
- Jan 31, 2008 · Not classified · Z-1053-2008: 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/K001019
Methodology: https://510kreport.com/methodology