# K070263: Apnealink

- Pathway: 510(k) (Traditional)
- Applicant: Resmed Germany, Inc.
- Decided: Jun 15, 2007 after 140 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: 6 generations back to K913396 (1992). 14 ancestors in all.
29 later devices descend from it; 2 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)
- K061405: Apnealink, Model 22302, Resmed Germany, Inc. (2006) Summary page 1.

## Most influential descendants
- K083575: Apnealink Plus, Model: 22328 (2009), 27 descendants of its own
- 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

## Indications for use
ApneaLink records patient respiratory nasal pressure and blood oxygen saturation during sleep. The device is intended for use as a screening device to determine the need for further clinical diagnosis based on the patient's test score. ApneaLink reports apneas, hypopneas, flow limitation, snoring, SpO2 and the probability of Cheyne-Stokes respiration breathing patterns within the recording.

Source page: https://510kreport.com/device/K070263
Methodology: https://510kreport.com/methodology