# K061405: Apnealink, Model 22302

- Pathway: 510(k) (Traditional)
- Applicant: Resmed Germany, Inc.
- Decided: Jul 25, 2006 after 67 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: 5 generations back to K913396 (1992). 13 ancestors in all.
30 later devices descend from it; 1 cites 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)
- K040576: Micromesam Basic-Set, Map Medizintechnik Fur Arzt Und Patient GmbH (2004) Summary page 1.
- K041724: Compass M10 System, Medcare Flaga (2004) Summary page 1.

## Most influential descendants
- K070263: Apnealink (2007), 29 descendants of its own
- 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

## 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 clinical diagnosis and evaluation by polysomnography based on the patient's test score.

Source page: https://510kreport.com/device/K061405
Methodology: https://510kreport.com/methodology