510(k) · Cleared
ClearedAviator Transport Incubator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Biomedical, Ltd. · FPL Incubator, Neonatal Transport
Cleared on Jun 6, 2008 after an 18-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- Jun 6, 2008
- Review
- 18 days
- Class
- Class II
- Product code
- FPL
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK081399 Aviator Transport IncubatorInternational Biomedical, Ltd. · 2008
- Descendant · cites it directly · 1 of its ownK103527 Aviator Transport Incubator with Masimo Pulseox, Aviator Transport…International Biomedical, Ltd. · 2011
- Descendant · 2 generations on · 0 of its ownK141565 Globe-Trotter GT5400Draeger Medical Systems, Inc. · 2014 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K081399 | Aviator Transport Incubator | International Biomedical, Ltd. | 2008 | — |
| +1 | K103527 | Aviator Transport Incubator with Masimo Pulseox, Aviator Transport Incubator… | International Biomedical, Ltd. | 2011 | — |
| +2 | K141565 | Globe-Trotter GT5400 | Draeger Medical Systems, Inc. | 2014 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103527 | Aviator Transport Incubator with Masimo Pulseox, Aviator Transport Incubator with… | 2011 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K103527 (International Biomedical, Ltd., 2011) has gone furthest, with 1 descendant 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. 2008, 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 transport incubator is intended to be used to transport neonatal infants including transport in ambulances or aircraft and to be used by personnel trained in neonatal care.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K081399 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081399: Aviator Transport Incubator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081399
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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