# K222950: AcuPebble OX100

- Pathway: 510(k) (Traditional)
- Applicant: Acurable Limited
- Decided: Feb 3, 2023 after 129 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: 4 generations back to K002135 (2000). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210480: AcuPebble SA, Acurable Limited (2021) Summary page 5.

## Most influential descendants
- K243092: AcuPebble Ox (200) (2025), 0 descendants of its own

## Indications for use
AcuPebble Ox100 is a wearable device intended for use in the recording, analysis, displaying, exporting, and storage of biophysical parameters to aid in the evaluation of adult patients with, or with suspected, obstructive sleep apnea (OSA). The device is primarily intended for home setting use (although can also be used in healthcare settings) under the direction of a Healthcare Professional (HCP).

Source page: https://510kreport.com/device/K222950
Methodology: https://510kreport.com/methodology