# K151874: BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal

- Pathway: 510(k) (Traditional)
- Applicant: Salter Labs
- Decided: Apr 15, 2016 after 281 days
- Product code: MNR (Ventilatory Effort Recorder)
- 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: 3 generations back to K913396 (1992). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051313: BI-Naps Nasal Airflow and Snore Transducer, Salter Labs (2005) Summary page 4.
- K080922: Salter Labs Oral/Nasal Thermal Airflow Sensor, Salter Labs, Division of Regulatory Affairs (2008) Summary page 4.

## Indications for use
The BiNAPS Nasal Airflow Pressure and Snore Transducer (using the pressure transducer) is an accessory intended for use with polysomnography equipment during sleep disorder studies for the purpose of detecting and amplifying breathing signals and detection of snoring of a sleeping patient through a Salter Labs nasal cannula. This device is intended for adult and pediatric (excluding neonatal and infant) use. The ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal is a thermal resistive thermistor designed to monitor oral/nasal thermal airflow temperature and pressure changes during sleep studies. The ThermiSense is intended for use with a nasal cannula and polysomnography headbox or pressure transducers, such as, BINAPS Nasal Airflow Transducer. This device is intended for adult and pediatric (excluding neonatal and infant) use.

Source page: https://510kreport.com/device/K151874
Methodology: https://510kreport.com/methodology