# K081176: Flochannel

- Pathway: 510(k) (Traditional)
- Applicant: Chad Therapeutics, Inc.
- Decided: Jul 28, 2008 after 94 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.
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)
- K982293: Pressure Transducer Airflow Sensor, Pro-Tech Services, Inc. (1998) Summary page 1.

## Indications for use
The FIoCHANNEL is intended for use during sleep disorder studies to detect respiratory airflow onto a physiological recorder. A filtered disposable nasal/oral cannula attaches to the patient and connects into the input of the FIoCHANNEL device. The outputs of the device provide low-voltage signals that are intended to be input into a physiological recorder. The FIoCHANNEL device can be used for pediatric patients, two years and older and adult patients including geriatric patients. The device is not intended for pediatrics and infants below two years of age for the purpose of respiration or SIDS monitoring.

Source page: https://510kreport.com/device/K081176
Methodology: https://510kreport.com/methodology