# K143272: ApneaLink Air

- Pathway: 510(k) (Traditional)
- Applicant: Resmed Germany, Inc.
- Decided: Apr 30, 2015 after 167 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: 9 generations back to K913396 (1992). 42 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131932: Apnealink Pro, Resmed Germany, Inc. (2013) Summary page 4.
- K082113: Nox T3, Noxturnal (PC Application), Nox Medical (2008) Summary page 4.

## Most influential descendants
- 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
- K242447: Falcon HST (2025), 0 descendants of its own

## Indications for use
The Apneal.ink™ Air 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 Air records the following data: patient respiratory nasal airflow, snoring, blood oxygen saturation, pulse, respiratory effort and body position 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/K143272
Methodology: https://510kreport.com/methodology