# K173793: XactTrace Single Use Respiratory Effort Belt System

- Pathway: 510(k) (Traditional)
- Applicant: Embla Systems
- Decided: Mar 1, 2019 after 442 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: 4 generations back to K000068 (2000). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043132: Universal Xacttrace, Medcare Flaga (2004) Summary page 4.
- K923402: Crystal Trace Piezo Respiratory Effort Sensor, Pro-Tech, Inc. (1992) Summary page 4.
- K042253: Sleepsense Sleep Sensors, S.L.P., Ltd. (2004) Summary page 4.

## Most influential descendants
- K242424: Bluebird Single-Use Respiratory Effort Belt (2024), 0 descendants of its own

## Indications for use
The XactTrace® Single Use Respiratory Effort Belt System is intended to measure respiratory effort to assist in the diagnosis of sleep disorders or sleep related respiratory disorders. The respiratory effort signals measured are processed to provide electrical signals suitable for connection to the inputs of physiological recording equipment. The intended environments are hospitals, institutions, sleep centers, sleep clinics. The XactTrace® Single Use Respiratory Effort Belt System is intended for diagnostics purposes only and is not intended to be used as an apnea monitor.

Source page: https://510kreport.com/device/K173793
Methodology: https://510kreport.com/methodology