510(k) · Cleared
ClearedNxtGen Infant Transport Incubator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Biomedical · FPL Incubator, Neonatal Transport
Cleared on Jul 15, 2022 as substantially equivalent to K103524 (International Biomedical, Ltd., 2011) after a 123-day review. Its family tree reaches back 3 generations to 1986.
- Decided
- Jul 15, 2022
- Review
- 123 days
- Class
- Class II
- Product code
- FPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K854065 (1986). No later device cites it as a predicate yet.
- Root · 3 generations backK854065 Infant Life Support Module-20Intl. Biomedics, Inc. · 1986
- 2 generations backK022876 Modification to Infant Life Support Module-20International Biomedical, Inc. · 2002
- 1 generation backK103524 Voyager Transport Incubator with Masimo Pulseox, Voyager Transport…International Biomedical, Ltd. · 2011
- This deviceK220742 NxtGen Infant Transport IncubatorInternational Biomedical · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K854065 | Infant Life Support Module-20 | Intl. Biomedics, Inc. | 1986 | — |
| −2 | K022876 | Modification to Infant Life Support Module-20 | International Biomedical, Inc. | 2002 | — |
| −1 | K103524 | Voyager Transport Incubator with Masimo Pulseox, Voyager Transport Incubator… | International Biomedical, Ltd. | 2011 | — |
| 0 (this device) | K220742 | NxtGen Infant Transport Incubator | International Biomedical | 2022 | — |
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K103524 | Voyager Transport Incubator with Masimo Pulseox, Voyager Transport Incubator with…Summary page 4…Regulation: 880.5410 Product Code: FPL Panel: General Hospital Predicate Device: International Biomedical – Voyager Infant Transport Incubator – K103524 Device Description: The NxtGen Infant Transport Incubator is designed to provide a thermally stable environment fo… | 2011 |
| † | K141565 | Globe-Trotter GT5400 | 2014 |
| † | K173516 | NuBorne Infant Warmer | 2018 |
| † | K160238 | Airborne Phototherapy Light | 2016 |
| † | K120168 | Lullaby Led Phottherapy System | 2012 |
| † | K771737 | Suction Canister | 1977 |
| † | K914601 | Suction Connecting Tubing | 1992 |
What descends from it?
No later submission names this one as a predicate yet.
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 36 years and passes through 4 companies; a new generation was cleared every 11.2 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All FPL devicesFPL Incubator, Neonatal Transport: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 NextGen 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 provides heat in a controlled manner to neonates through an enclosed temperature controlled environment. The transport incubator is also intended to carry equipment designed for airway management and monitoring of the neonatal infant’s status. The device provides two modes of heat…
Read the full statement (110 words)
The NextGen 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 provides heat in a controlled manner to neonates through an enclosed temperature controlled environment. The transport incubator is also intended to carry equipment designed for airway management and monitoring of the neonatal infant’s status. The device provides two modes of heat: Manual (operator) controlled or Skin (servo) controlled. All transport incubators may be optionally configured with pulse oximetry, a suction device, and an integrated heated mattress. In addition, the NextGen Incubator may be configured with optional blue LED phototherapy to treat indirect hyperbilirubinemia.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K220742 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220742: NxtGen Infant Transport Incubator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220742
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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