De Novo · Granted
GrantedORi
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Masimo Corporation · QWE Hyperoxia Monitoring Device Adjunct To Pulse Oximetry
Granted on Oct 12, 2023 as a new device type through De Novo after a 1,025-day review.
- Decided
- Oct 12, 2023
- Review
- 1,025 days
- Class
- Class II
- Product code
- QWE
- 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 QWE? 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 QWE devicesQWE Hyperoxia Monitoring Device Adjunct To Pulse Oximetry: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QWE
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QWE
Too few QWE 510(k)s in any year since 2007 to give a median.
Recalls per year · QWE
No recall names QWE since 2007.
Adverse event reports per year · QWE
1in 2025
MAUDE reports naming product code QWE, 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 | 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 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ORi feature is intended to be used in patients undergoing surgery as an adjunct to SpO2 for increased monitoring resolution of elevated hemoglobin oxygen saturation levels (e.g., due to the administration of supplemental oxygen).
The ORi feature is indicated for the monitoring of hemoglobin oxygen saturation levels in patients 18 years and older (adults and transitional adolescents) on supplemental oxygen during no-motion conditions perioperatively in hospital environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN200076 · printed Nov 3, 2026
Cite this page
510(k) Report. “DEN200076: ORi.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/DEN200076
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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