# K210480: AcuPebble SA

- Pathway: 510(k) (Traditional)
- Applicant: Acurable Limited
- Decided: Jul 6, 2021 after 137 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: 3 generations back to K002135 (2000). 3 ancestors in all.
2 later devices descend 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)
- K173974: Drowzle, Resonea, Inc. (2019) Summary page 5.

## Most influential descendants
- K222950: AcuPebble OX100 (2023), 1 descendant of its own
- K243092: AcuPebble Ox (200) (2025), 0 descendants of its own

## Indications for use
AcuPebble SA100 is indicated to sense, record, and interpret a patient’s physiological signals (including respiratory pattern) during sleep for the purpose of prescreening patients for obstructive sleep apnea (OSA) syndrome. The device is designed for use in home-screening of adults with suspected possible sleep breathing disorders (although it can also be used in clinic). Results are used to assist the healthcare professional's in the patient's evaluation. The system is not intended as a substitute for full polysomnography when additional parameters such as sleep stages, limb movements, or EEG activity are required.

Source page: https://510kreport.com/device/K210480
Methodology: https://510kreport.com/methodology