510(k) · Cleared
ClearedModification to Infant Life Support Module-20
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Biomedical, Inc. · FPL Incubator, Neonatal Transport
Cleared on Sep 11, 2002 as substantially equivalent to K854065 (Intl. Biomedics, Inc., 1986) after a 12-day review. Its family tree reaches back 1 generation to 1986. 2 later devices descend from it.
- Decided
- Sep 11, 2002
- Review
- 12 days
- Class
- Class II
- Product code
- FPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K854065 (1986). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK854065 Infant Life Support Module-20Intl. Biomedics, Inc. · 1986
- This deviceK022876 Modification to Infant Life Support Module-20International Biomedical, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK103524 Voyager Transport Incubator with Masimo Pulseox, Voyager Transport…International Biomedical, Ltd. · 2011
- Descendant · 2 generations on · 0 of its ownK220742 NxtGen Infant Transport IncubatorInternational Biomedical · 2022
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 |
|---|---|---|---|---|---|
| −1 | K854065 | Infant Life Support Module-20 | Intl. Biomedics, Inc. | 1986 | — |
| 0 (this device) | 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 | — |
| +2 | K220742 | NxtGen Infant Transport Incubator | International Biomedical | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K854065 | Infant Life Support Module-20Summary page 3…Radiological Health Enclosure Indications for Use Statement (ref. K022876) 51O(k) number - K854065 ( modified device) Device name: Infant Life Support Module - 20 Indications for Use: The “Infant Life Support Module -… | 1986 |
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 |
|---|---|---|---|
| K103524 | Voyager Transport Incubator with Masimo Pulseox, Voyager 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?
- Its one ancestor has no recall.
- Of its descendants, K103524 (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.
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 “Infant Life Support Module - 20” is a neonatal transport incubator. The incubator circulates warmed air at an operator selected, controlled temperature into a transparent chamber containing an infant. The structural integrity and weight of the incubator makes it suitable for ground and air transport. Auxiliary equipment for airway management and vital signs monitoring is usually present. The system is to be operated by trained medical technical personnel. Intended use of the modified (K022876) and predicate device ( K854065)are identical.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K022876 · printed Nov 5, 2026
Cite this page
510(k) Report. “K022876: Modification to Infant Life Support Module-20.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022876
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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