510(k) · Cleared
ClearedTransport Incubator 185
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Airborne Life Support Systems, Inc. · FPL Incubator, Neonatal Transport
Cleared on May 23, 1985 after a 104-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- May 23, 1985
- Review
- 104 days
- Class
- Class II
- Product code
- FPL
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK850496 Transport Incubator 185Airborne Life Support Systems, Inc. · 1985
- Descendant · cites it directly · 3 of its ownK031096 Modification to Transport Incubator 185International Biomedics, Inc. · 2003
- Descendant · 2 generations on · 0 of its ownK103525 A750I Transport Incubator with Masimo Pluseox, A750I Transport…International Biomedical, Ltd. · 2011
- Descendant · 2 generations on · 0 of its ownK103523 185A+ Transport Incubator with Masimo Pulseox, 185A+ Transport…International Biomedical, Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK081264 Statstrap Neonatal Incubator Safety Strap, Models SS-001, SS-002Children'S Health First, Inc. · 2009
Most influential descendants
Showing 4 of 4 · See all- K031096Modification to Transport Incubator 185International Biomedics, Inc. · 2003 · cites it directly3descendants
- K103525A750I Transport Incubator with Masimo Pluseox, A750I Transport Incubator with Nellor…International Biomedical, Ltd. · 2011 · 2 generations on0descendants
- K103523185A+ Transport Incubator with Masimo Pulseox, 185A+ Transport Incubator with Nellcor…International Biomedical, Ltd. · 2011 · 2 generations on0descendants
- K081264Statstrap Neonatal Incubator Safety Strap, Models SS-001, SS-002Children'S Health First, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K850496 | Transport Incubator 185 | Airborne Life Support Systems, Inc. | 1985 | — |
| +1 | K031096 | Modification to Transport Incubator 185 | International Biomedics, Inc. | 2003 | — |
| +2 | K103525 | A750I Transport Incubator with Masimo Pluseox, A750I Transport Incubator with… | International Biomedical, Ltd. | 2011 | — |
| +2 | K103523 | 185A+ Transport Incubator with Masimo Pulseox, 185A+ Transport Incubator with… | International Biomedical, Ltd. | 2011 | — |
| +1 | K081264 | Statstrap Neonatal Incubator Safety Strap, Models SS-001, SS-002 | Children'S Health First, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K031096 (International Biomedics, Inc., 2003) has gone furthest, with 3 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.
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 | — |
https://510kreport.com/device/K850496 · printed Nov 6, 2026
Cite this page
510(k) Report. “K850496: Transport Incubator 185.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K850496
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026