# K082113: Nox T3, Noxturnal (PC Application)

- Pathway: 510(k) (Traditional)
- Applicant: Nox Medical
- Decided: Nov 7, 2008 after 102 days
- Product code: MNR (Ventilatory Effort Recorder)
- Device class: 2
- Regulation: 21 CFR 868.2375
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K910772 (1991). 26 ancestors in all.
17 later devices descend from it; 4 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024322: Embla N7000, Medcare Flaga (2003) Summary page 1.
- K041724: Compass M10 System, Medcare Flaga (2004) Summary page 1.
- K043359: 4100 Patient Oximeter Module, Nonin Medical, Inc. (2005) Summary page 1.

## Most influential descendants
- K143272: ApneaLink Air (2015), 7 descendants of its own
- K163665: MATRx plus (2017), 3 descendants of its own
- K124062: QDC-Pro, and Nox-Rip (2013), 3 descendants of its own
- K120462: Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered Breathing Detection) (2012), 3 descendants of its own
- K181996: MATRx Plus (2018), 2 descendants of its own

## Recalls of this device
- Sep 7, 2021 · Class II · Z-0031-2022: Error in the device firmware results in the inaccurate detection of device position.

## Indications for use
The Nox T3 device is intended for ambulatory recording of physiological signals during sleep. The recorded signals are then downloaded to a PC where the signals can be viewed and analyzed by use of the Nox T3 application (Noxturnal). The Nox T3 system is indicated for use in patients greater than 2 years of age. The Nox T3 system is NOT intended for any patient monitoring or automatic diagnosis. The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments, including patient's home.

Source page: https://510kreport.com/device/K082113
Methodology: https://510kreport.com/methodology