De Novo · Granted
GrantedBrainTemp Neonate System (BTNeo System)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brain Temp, Inc. · QSL Brain Temperature Measurement System
Granted on Mar 29, 2022 as a new device type through De Novo after a 644-day review.
- Decided
- Mar 29, 2022
- Review
- 644 days
- Class
- Class II
- Product code
- QSL
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo 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 QSL? 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
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.
How does its category compare?
All QSL devicesQSL Brain Temperature Measurement System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · QSL
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · QSL
Too few QSL 510(k)s in any year since 2007 to give a median.
Recalls per year · QSL
No recall names QSL since 2007.
Adverse event reports per year · QSL
No MAUDE report names QSL since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The BTNeo System is indicated for measurement of a neonate’s brain temperature. The brain temperature may be displayed with a compatible vital sign monitor system and is intended to be displayed along with core temperature.
The BTNeo System is indicated for use by qualified healthcare professionals that care for neonates (from birth through the first 28 days of life) in intensive care units, operating rooms, and recovery rooms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN200042 · printed Nov 3, 2026
Cite this page
510(k) Report. “DEN200042: BrainTemp Neonate System (BTNeo System).” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/DEN200042
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026