# K242424: Bluebird Single-Use Respiratory Effort Belt

- Pathway: 510(k) (Traditional)
- Applicant: Cadwell Industries, Inc.
- Decided: Dec 18, 2024 after 125 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: 5 generations back to K000068 (2000). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173793: XactTrace Single Use Respiratory Effort Belt System, Embla Systems (2019) Summary page 5.

## Indications for use
The Bluebird Single-Use Respiratory Effort Belt is intended to measure respiratory effort to assist in the diagnosis of sleep disorders or sleep related respiratory disorders. The respiratory effort belt signals are suitable for connection to sleep/polysomnography (PSG) systems. The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments, including the patient's home. The Bluebird Single-Use Respiratory Effort Belt is intended for diagnostic purposes only on patients greater than 2 years of age and is not intended to be used as an apnea monitor.

Source page: https://510kreport.com/device/K242424
Methodology: https://510kreport.com/methodology