# K080922: Salter Labs Oral/Nasal Thermal Airflow Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Salter Labs, Division of Regulatory Affairs
- Decided: Jul 25, 2008 after 115 days
- Product code: BZQ (Monitor, Breathing Frequency)
- Device class: 2
- Regulation: 21 CFR 868.2375
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K981445 (1998). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981445: Ultima Airflow Sensor, 0510, Braebon Medical Corp. (1998) Summary page 1.

## Most influential descendants
- K161953: ReDe Mask (2017), 0 descendants of its own
- K151874: BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal (2016), 0 descendants of its own
- K092685: Pneumotherml, Model:  5800 (2009), 0 descendants of its own

## Recalls of this device
- Dec 21, 2010 · Not classified · Z-1028-2011: The incorrect length and connector were utilized in lot 110810 of the ThermiSense Alice 5, making the product unusable as it will not interface with the sleep labs equipment.

## Indications for use
The Salter Labs Oral/Nasal Thermal Airflow Sensor is used as a cannula accessory with existing recording devices and data acquisition systems in a sleep laboratory setting to support the diagnostic recording of nasal and/or oral airflow. The subject device itself performs no diagnostic functions, and only supports the diagnostic recording of airflow for use as an accessory component to a polysomnography recorder. The target population is adult and pediatric patients during a sleep study in a sleep laboratory.

Source page: https://510kreport.com/device/K080922
Methodology: https://510kreport.com/methodology