# K051313: BI-Naps Nasal Airflow and Snore Transducer

- Pathway: 510(k) (Traditional)
- Applicant: Salter Labs
- Decided: Sep 15, 2005 after 119 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: 2 generations back to K913396 (1992). 2 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982293: Pressure Transducer Airflow Sensor, Pro-Tech Services, Inc. (1998) Summary page 1.

## Most influential descendants
- 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
- K082853: Clinical Oxygen Dose Recorder (Codr), Model 300-CR (2009), 0 descendants of its own
- K080983: Provent Nasal Cannula (2008), 0 descendants of its own

## Indications for use
The Salter Labs BiNAPS Airflow 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.

Source page: https://510kreport.com/device/K051313
Methodology: https://510kreport.com/methodology