510(k) · Cleared
ClearedModification to Transport Incubator 185
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Biomedics, Inc. · FPL Incubator, Neonatal Transport
Cleared on Jun 24, 2003 as substantially equivalent to K850496 (Airborne Life Support Systems, Inc., 1985) after a 78-day review. Its family tree reaches back 1 generation to 1985. 3 later devices descend from it.
- Decided
- Jun 24, 2003
- Review
- 78 days
- Class
- Class II
- Product code
- FPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K850496 (1985). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK850496 Transport Incubator 185Airborne Life Support Systems, Inc. · 1985
- This deviceK031096 Modification to Transport Incubator 185International Biomedics, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK103525 A750I Transport Incubator with Masimo Pluseox, A750I Transport…International Biomedical, Ltd. · 2011
- Descendant · cites it directly · 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 3 of 3 · See all- K103525A750I Transport Incubator with Masimo Pluseox, A750I Transport Incubator with Nellor…International Biomedical, Ltd. · 2011 · cites it directly0descendants
- K103523185A+ Transport Incubator with Masimo Pulseox, 185A+ Transport Incubator with Nellcor…International Biomedical, Ltd. · 2011 · cites it directly0descendants
- 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 |
|---|---|---|---|---|---|
| −1 | K850496 | Transport Incubator 185 | Airborne Life Support Systems, Inc. | 1985 | — |
| 0 (this device) | K031096 | Modification to Transport Incubator 185 | International Biomedics, Inc. | 2003 | — |
| +1 | K103525 | A750I Transport Incubator with Masimo Pluseox, A750I Transport Incubator with… | International Biomedical, Ltd. | 2011 | — |
| +1 | 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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 2 | 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 |
|---|---|---|---|
| * | K850496 | Transport Incubator 185Summary page 3…tal signs monitoring are not standard equipment.. The system is to be operated by trained medical technical personnel. Intended use of the modified and predicate device (K850496A) are identical. , ?, Name +-At-& (!.Y <’Lr---- / Title… | 1985 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103525 | A750I Transport Incubator with Masimo Pluseox, A750I Transport Incubator with Nellor… | 2011 | 0 |
| K103523 | 185A+ Transport Incubator with Masimo Pulseox, 185A+ Transport Incubator with Nellcor… | 2011 | 0 |
| K081264 | Statstrap Neonatal Incubator Safety Strap, Models SS-001, SS-002 | 2009 | 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?
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 “Transport Incubator 185A” 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 are not standard equipment.. The system is to be operated by trained medical technical personnel. Intended use of the modified and predicate device (K850496A) are identical.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K031096 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031096: Modification to 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/K031096
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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