# K971501: Sleepscan Airflow Pressure Transducer

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Logic Systems Corp.
- Decided: Oct 14, 1997 after 173 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: 1 generation back to K913396 (1992). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913396: Cannula Style Thermocouples, Pro-Tech, Inc. (1992) Summary page 1.

## Most influential descendants
- K080983: Provent Nasal Cannula (2008), 0 descendants of its own

## Indications for use
The Bio-logic Airflow Pressure Transducer is indicated for use during sleep disorder studies to detect respiratory airflow for recording onto a physiological recorder. It is a battery-powered device, with a disposable nasal cannula which attaches to the patient and plugs into the input of the Airflow Pressure Transducer device. The outputs of the device provide low-level voltage signals which are intended to be input to a physiological recorder (such as the Bio-logic Sleepscan product). It can be used for patients of all ages, from newborn infants through adults, to and including geriatric patients.

Source page: https://510kreport.com/device/K971501
Methodology: https://510kreport.com/methodology