# K131932: Apnealink Pro

- Pathway: 510(k) (Traditional)
- Applicant: Resmed Germany, Inc.
- Decided: Nov 8, 2013 after 134 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: 8 generations back to K913396 (1992). 26 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083575: Apnealink Plus, Model: 22328, Resmed Germany, Inc. (2009) Summary page 1.

## Most influential descendants
- K143272: ApneaLink Air (2015), 7 descendants of its own
- K163665: MATRx plus (2017), 3 descendants of its own
- K181996: MATRx Plus (2018), 2 descendants of its own
- K172986: Zmachine Synergy (2017), 2 descendants of its own
- K191925: MATRx Plus (2019), 1 descendant of its own

## Indications for use
The ApneaLink' Pro device is indicated for use by Health Care Professionals (HCP), where it may aid in the diagnosis of sleep disordered breathing for adult patients. ApneaLink Pro records the following data: patient respiratory nasal airflow, snoring, blood oxygen saturation, pulse and respiratory effort during sleep. The device uses these recordings to produce a report for the HCP that may aid in the diagnosis of sleep disordered breathing or for further clinical investigation. The device is intended for home and hospital use under the direction of a HCP.

Source page: https://510kreport.com/device/K131932
Methodology: https://510kreport.com/methodology