# K080983: Provent Nasal Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Ventus Medical, Inc.
- Decided: Aug 7, 2008 after 122 days
- Product code: MNR (Ventilatory Effort Recorder)
- 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: 3 generations back to K913396 (1992). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 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 1.
- K984431: Ultima Airflow Pressure Sensor, Braebon Medical Corp. (1998) Summary page 1.
- K971501: Sleepscan Airflow Pressure Transducer, Bio-Logic Systems Corp. (1997) Summary page 1.
- K053063: Pro-Flow Multipurpose Cannula, Pro-Tech Services, Inc. (2005) Summary page 1.

## Recalls of this device
- Dec 3, 2009 · Not classified · Z-2435-2010: The catalog number printed on two Nasal Cannula Diagnostic Kits (MRS0231) was different that the catalog number printed on the bulk pack shipper box and the other Nasal Cannula Kits in the same shippe

## Indications for use
The Provent Nasal Cannula is indicated for the transmission of respiratory airflow signals between the ProventTM Professional Sleep Apnea Therapy device and the pressure transducers used with physiologic recorders during sleep studies.

Source page: https://510kreport.com/device/K080983
Methodology: https://510kreport.com/methodology