510(k) · Cleared
ClearedAviator Transport Incubator with Masimo Pulseox, Aviator Transport Incubator with Nellcor Pulseox
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 Apr 15, 2011 as substantially equivalent to K081399 (International Biomedical, Ltd., 2008) after a 135-day review. Its family tree reaches back 1 generation to 2008. 1 later device descends from it.
- Decided
- Apr 15, 2011
- Review
- 135 days
- Class
- Class II
- Product code
- FPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K081399 (2008). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK081399 Aviator Transport IncubatorInternational Biomedical, Ltd. · 2008
- This deviceK103527 Aviator Transport Incubator with Masimo Pulseox, Aviator Transport…International Biomedical, Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK141565 Globe-Trotter GT5400Draeger Medical Systems, Inc. · 2014 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K141565Globe-Trotter GT5400Draeger Medical Systems, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K081399 | Aviator Transport Incubator | International Biomedical, Ltd. | 2008 | — |
| 0 (this device) | K103527 | Aviator Transport Incubator with Masimo Pulseox, Aviator Transport Incubator… | International Biomedical, Ltd. | 2011 | — |
| +1 | K141565 | Globe-Trotter GT5400 | Draeger Medical Systems, Inc. | 2014 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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? (1)
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 |
|---|---|---|---|
| * | K081399 | Aviator Transport IncubatorSummary page 1…x Common Name: Transport Incubator Classification Name: Neonatal Transport Incubator (FPL) Predicate Device: Aviator Transport Incubator (k08 1399) Intended Use: The transport incubator is intended for use by personnel trained in neonatal care to facilitate the… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141565 | Globe-Trotter GT5400 | 2014 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K141565 (Draeger Medical Systems, Inc., 2014) has gone furthest, with 0 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. 2011, 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 for use by personnel trained in neonatal care to facilitate the movements of neonates by air or ambulance.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103527 · printed Nov 5, 2026
Cite this page
510(k) Report. “K103527: Aviator Transport Incubator with Masimo Pulseox, Aviator Transport Incubator with Nellcor Pulseox.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103527
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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