# K043132: Universal Xacttrace

- Pathway: 510(k) (Traditional)
- Applicant: Medcare Flaga
- Decided: Dec 21, 2004 after 39 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: 3 generations back to K000068 (2000). 6 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923402: Crystal Trace Piezo Respiratory Effort Sensor, Pro-Tech, Inc. (1992) Summary page 1.
- K040194: Compumedics Summit IP, Compumedics USA, Ltd. (2004) Summary page 1.

## Most influential descendants
- K090273: Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai Rspot, Model 100 (2009), 7 descendants of its own
- K151940: Thora-3Di, Model T-01 (2016), 3 descendants of its own
- K242001: Philips VSC-MEDlib (2025), 2 descendants of its own
- K243966: FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) (2025), 1 descendant of its own
- K173793: XactTrace Single Use Respiratory Effort Belt System (2019), 1 descendant of its own

## Indications for use
Universal XactTrace 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, or other test environments. Universal XactTrace is intended for diagnostics purposes only and is not intended to be used as an apnea monitor.

Source page: https://510kreport.com/device/K043132
Methodology: https://510kreport.com/methodology