510(k) · Cleared
ClearedReDe Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tereopneuma · PRK Device Indicating An Exhalation Event
Cleared on Feb 17, 2017 as substantially equivalent to K080922 (Salter Labs, Division of Regulatory Affairs, 2008) after a 214-day review. Its family tree reaches back 2 generations to 1998.
- Decided
- Feb 17, 2017
- Review
- 214 days
- Class
- Class II
- Product code
- PRK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K981445 (1998). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 PRK? 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
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 |
|---|---|---|---|
| * | K080922 | Salter Labs Oral/Nasal Thermal Airflow SensorSummary page 4…e Device Trade Name: Oral/Nasal Thermal Airflow Sensor Device Common Name Airflow Sensor 510(k) Number: K080922 (cleared 7/2008) Manufacturer: Salter Labs Reference Devices Two reference devices are used in the clini… | 2008 |
| † | K964239 | Combination Oximeter/Carbon Dioxide Gas Analyzer | 1997 |
| † | K120087 | Exspiron | 2012 |
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 19 years and passes through 3 companies; a new generation was cleared every 9.8 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 2 other devices also cite its predicate K080922.
How does its category compare?
All PRK devicesPRK Device Indicating An Exhalation Event: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · PRK
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · PRK
Too few PRK 510(k)s in any year since 2007 to give a median.
Recalls per year · PRK
No recall names PRK since 2007.
Adverse event reports per year · PRK
No MAUDE report names PRK 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 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ReDe Mask is indicated for use by healthcare professionals in healthcare facility procedural areas and recovery rooms as an adjunct to monitor breathing in adult patients who are sedated for a diagnostic or therapeutic procedure. The ReDe Mask measures the time period between the current and previous exhalation and illuminates a colored light during the exhalation that reflects the interval of time between breaths. If the interval is less than 7.5…
Read the full statement (150 words)
The ReDe Mask is indicated for use by healthcare professionals in healthcare facility procedural areas and recovery rooms as an adjunct to monitor breathing in adult patients who are sedated for a diagnostic or therapeutic procedure. The ReDe Mask measures the time period between the current and previous exhalation and illuminates a colored light during the exhalation that reflects the interval of time between breaths. If the interval is less than 7.5 seconds, the green light illuminates during exhalation; if the interval is greater than 7.5 seconds but up to 20 seconds, the yellow light illuminates during exhalation; and if the interval between breaths is 20 seconds or longer, the red light flashes continuously. The ReDe Mask is only to be used when supplemental oxygen is provided by the facemask. The ReDe Mask is not a standalone device and is only to be used as an adjunct to pulse oximetry.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161953 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161953: ReDe Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161953
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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