510(k) · Cleared
Recalled · Class II · 2022Globe-Trotter GT5400
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Draeger Medical Systems, Inc. · FPL Incubator, Neonatal Transport
Cleared on Sep 10, 2014 as substantially equivalent to K001019 (Hill-Rom Air-Shields, 2000) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 2008. It has been recalled once.
- Decided
- Sep 10, 2014
- Review
- 90 days
- Class
- Class II
- Product code
- FPL
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K081399 (2008). 3 ancestors in all, the oldest K001019 (2000). No later device cites it as a predicate yet.
- Root · 2 generations backK081399 Aviator Transport IncubatorInternational Biomedical, Ltd. · 2008
- 1 generation backK103527 Aviator Transport Incubator with Masimo Pulseox, Aviator Transport…International Biomedical, Ltd. · 2011
- This deviceK141565 Globe-Trotter GT5400Draeger Medical Systems, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K081399 | Aviator Transport Incubator | International Biomedical, Ltd. | 2008 | — |
| −1 | K103527 | Aviator Transport Incubator with Masimo Pulseox, Aviator Transport Incubator… | International Biomedical, Ltd. | 2011 | — |
| 0 (this device) | K141565 | Globe-Trotter GT5400 | Draeger Medical Systems, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FPL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FPL device
- #1 K220742 NxtGen Infant Transport Incubatorscore 4.3 · 3 generations · no Class I recall
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K001019 | TI500 Globe-Trotter Transport SystemSummary page 4…P Class: II Legally Marketed Device Identification: Substantial equivalence is claimed to the Tl500 Globe-Trotter Transport System K001 019, Aviator Transport Incubator K1 03527. Intended Use: The Globe-Trotter GT5400 (GT5400) is a neonatal transport system intended… | 2000 |
| * | K103527 | Aviator Transport Incubator with Masimo Pulseox, Aviator Transport Incubator with…Summary page 4…II Legally Marketed Device Identification: Substantial equivalence is claimed to the Tl500 Globe-Trotter Transport System K001 019, Aviator Transport Incubator K1 03527. Intended Use: The Globe-Trotter GT5400 (GT5400) is a neonatal transport system intended for the transport of new- borns weighi… | 2011 |
| † | K870173 | Lavabed System & Chamber, Lavapak Temp. Control | 1987 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 20, 2022 | Class II | Z-1365-2022 | Under Investigation by firm | The firm has initiated this recall to replace component on devices distributed containing a component within the oxygen supply system that is not rated to the working pressure of the system. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 3.4 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 2 other devices also cite its predicate K001019.
How does its category compare?
All FPL devicesFPL Incubator, Neonatal Transport: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · FPL
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · FPL
148in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FPL
No recall names FPL since 2007.
Adverse event reports per year · FPL
3in 2024
MAUDE reports naming product code FPL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 4 | 148 | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 3 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Globe-Trotter GT5400 neonatal transport system is intended for the transport of newborns weighing up to 10 kg (22
lb) between healthcare facilities. It provides means to control air temperature, deliver oxygen, resuscitate, provide passive
humidification, and ventilate with active humidification (optional).
The Globe-Trotter GT5400 neonatal transport system is intended for use by trained health care professionals and is not
intended for home use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141565 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141565: Globe-Trotter GT5400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141565
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026