510(k) · Cleared
ClearedVoyager Transport Incubator with Masimo Pulseox, Voyager 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 K022876 (International Biomedical, Inc., 2002) after a 135-day review. Its family tree reaches back 2 generations to 1986. 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 2 generations to K854065 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK854065 Infant Life Support Module-20Intl. Biomedics, Inc. · 1986
- 1 generation backK022876 Modification to Infant Life Support Module-20International Biomedical, Inc. · 2002
- This deviceK103524 Voyager Transport Incubator with Masimo Pulseox, Voyager Transport…International Biomedical, Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK220742 NxtGen Infant Transport IncubatorInternational Biomedical · 2022
Most influential descendants
Showing 1 of 1 · See all- K220742NxtGen Infant Transport IncubatorInternational Biomedical · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K854065 | Infant Life Support Module-20 | Intl. Biomedics, Inc. | 1986 | — |
| −1 | K022876 | Modification to Infant Life Support Module-20 | International Biomedical, Inc. | 2002 | — |
| 0 (this device) | K103524 | Voyager Transport Incubator with Masimo Pulseox, Voyager Transport Incubator… | International Biomedical, Ltd. | 2011 | — |
| +1 | K220742 | NxtGen Infant Transport Incubator | International Biomedical | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 |
|---|---|---|---|
| * | K022876 | Modification to Infant Life Support Module-20Summary page 1…Common Name: Transport Incubator Classification Name: Neonatal Transport Incubator (FPL) Predicate Device: Infant Life Support Module - 20 (k022876) Intended Use: The transport incubator is intended for use by personnel trained in neonatal care to facilitate the… | 2002 |
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 |
|---|---|---|---|
| K220742 | NxtGen Infant Transport Incubator | 2022 | 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?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 16.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K220742 (International Biomedical, 2022) 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. The transport incubator circulates warmed air at an operator selected and controlled temperature when transporting neonatal infants to hospitals prepared for neonatal infant care. The transport incubator is also intended to carry equipment designed for airway management and monitoring of the neonatal infant's status.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103524 · printed Nov 5, 2026
Cite this page
510(k) Report. “K103524: Voyager Transport Incubator with Masimo Pulseox, Voyager 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/K103524
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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