# K083575: Apnealink Plus, Model: 22328

- Pathway: 510(k) (Traditional)
- Applicant: Resmed Germany, Inc.
- Decided: Mar 19, 2009 after 106 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: 7 generations back to K913396 (1992). 25 ancestors in all.
27 later devices descend from it; 3 cite it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070263: Apnealink, Resmed Germany, Inc. (2007) Summary page 1.
- K021845: Stardust II, Model 1011176, Respironics, Inc. (2004) Summary page 1.

## Most influential descendants
- K140124: S9 Elouera (2014), 8 descendants of its own
- K132371: Easycare Online (2013), 8 descendants of its own
- K131932: Apnealink Pro (2013), 8 descendants of its own
- K143272: ApneaLink Air (2015), 7 descendants of its own
- K160836: Menai System (2016), 6 descendants of its own

## Indications for use
The ApneaLink TM Plus 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 Plus 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.

Source page: https://510kreport.com/device/K083575
Methodology: https://510kreport.com/methodology