# K092685: Pneumotherml, Model:  5800

- Pathway: 510(k) (Special)
- Applicant: Salter Labs
- Decided: Nov 24, 2009 after 83 days
- Product code: BZQ (Monitor, Breathing Frequency)
- 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)

## 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/K092685
Methodology: https://510kreport.com/methodology