# K161953: ReDe Mask

- Pathway: 510(k) (Traditional)
- Applicant: Tereopneuma
- Decided: Feb 17, 2017 after 214 days
- Product code: PRK (Device Indicating An Exhalation Event)
- Device class: 2
- Regulation: 21 CFR 868.2375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K981445 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080922: Salter Labs Oral/Nasal Thermal Airflow Sensor, Salter Labs, Division of Regulatory Affairs (2008) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K161953
Methodology: https://510kreport.com/methodology