510(k) · Cleared
Recalled · 2008TI500 Globe-Trotter Transport System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hill-Rom Air-Shields · FPL Incubator, Neonatal Transport
Cleared on Apr 27, 2000 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 27, 2000
- Review
- 28 days
- Class
- Class II
- Product code
- FPL
- Recalls
- 2
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK001019 TI500 Globe-Trotter Transport SystemHill-Rom Air-Shields · 2000
- Descendant · cites it directly · 2 of its ownK033565 LMT Nomag IC 1,5Lmt Lammers Medical Technology GmbH · 2003
- Descendant · 2 generations on · 1 of its ownK062052 LMT Nomag IC 3.0Lmt Lammers Medical Technology GmbH · 2006
- Descendant · 2 generations on · 0 of its ownK161918 SREE MRI Transport IncubatorAdvanced Imaging Research Dba Sree Medical Systems · 2017
- Descendant · cites it directly · 0 of its ownK141565 Globe-Trotter GT5400Draeger Medical Systems, Inc. · 2014 · Recalled
- Descendant · cites it directly · 0 of its ownK081264 Statstrap Neonatal Incubator Safety Strap, Models SS-001, SS-002Children'S Health First, Inc. · 2009
Most influential descendants
Showing 5 of 5 · See all- K033565LMT Nomag IC 1,5Lmt Lammers Medical Technology GmbH · 2003 · cites it directly2descendants
- K062052LMT Nomag IC 3.0Lmt Lammers Medical Technology GmbH · 2006 · 2 generations on1descendant
- K161918SREE MRI Transport IncubatorAdvanced Imaging Research Dba Sree Medical Systems · 2017 · 2 generations on0descendants
- K141565Globe-Trotter GT5400Draeger Medical Systems, Inc. · 2014 · cites it directly0descendants
- K081264Statstrap Neonatal Incubator Safety Strap, Models SS-001, SS-002Children'S Health First, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001019 | TI500 Globe-Trotter Transport System | Hill-Rom Air-Shields | 2000 | — |
| +1 | K033565 | LMT Nomag IC 1,5 | Lmt Lammers Medical Technology GmbH | 2003 | — |
| +2 | K062052 | LMT Nomag IC 3.0 | Lmt Lammers Medical Technology GmbH | 2006 | — |
| +2 | K161918 | SREE MRI Transport Incubator | Advanced Imaging Research Dba Sree Medical Systems | 2017 | — |
| +1 | K141565 | Globe-Trotter GT5400 | Draeger Medical Systems, Inc. | 2014 | 1 |
| +1 | K081264 | Statstrap Neonatal Incubator Safety Strap, Models SS-001, SS-002 | Children'S Health First, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 31, 2008 | Not classified | Z-1052-2008 | Nonconforming Material/Component | 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 patient compartment. |
| Jan 31, 2008 | Not classified | Z-1053-2008 | Nonconforming Material/Component | 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 patient compartment. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K033565 (Lmt Lammers Medical Technology GmbH, 2003) has gone furthest, with 2 descendants of its own.
How does its category compare?
All FPL devicesFPL Incubator, Neonatal Transport: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K001019 · printed Nov 4, 2026
Cite this page
510(k) Report. “K001019: TI500 Globe-Trotter Transport System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K001019
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026