510(k) · Cleared
Cleared185A+ Transport Incubator with Masimo Pulseox, 185A+ 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 May 11, 2011 as substantially equivalent to K031096 (International Biomedics, Inc., 2003) after a 161-day review. Its family tree reaches back 2 generations to 1985.
- Decided
- May 11, 2011
- Review
- 161 days
- Class
- Class II
- Product code
- FPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K850496 (1985). No later device cites it as a predicate yet.
- Root · 2 generations backK850496 Transport Incubator 185Airborne Life Support Systems, Inc. · 1985
- 1 generation backK031096 Modification to Transport Incubator 185International Biomedics, Inc. · 2003
- This deviceK103523 185A+ Transport Incubator with Masimo Pulseox, 185A+ Transport…International Biomedical, Ltd. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K850496 | Transport Incubator 185 | Airborne Life Support Systems, Inc. | 1985 | — |
| −1 | K031096 | Modification to Transport Incubator 185 | International Biomedics, Inc. | 2003 | — |
| 0 (this device) | K103523 | 185A+ Transport Incubator with Masimo Pulseox, 185A+ Transport Incubator with… | International Biomedical, Ltd. | 2011 | — |
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 |
|---|---|---|---|
| * | K031096 | Modification to Transport Incubator 185Summary page 1…Common Name: Transport Incubator Classification Name: Neonatal Transport Incubator (FPL) Predicate Device: Transport Incubator 185A Incubator (k03 1096) Intended Use: The transport incubator is a neonatal transport incubator. The incubator circulates warmed air at a… | 2003 |
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 26 years and passes through 3 companies; a new generation was cleared every 18.1 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K031096.
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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103523 · printed Nov 5, 2026
Cite this page
510(k) Report. “K103523: 185A+ Transport Incubator with Masimo Pulseox, 185A+ 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/K103523
Report an extraction error
Are you the manufacturer?
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