# K173974: Drowzle

- Pathway: 510(k) (Traditional)
- Applicant: Resonea, Inc.
- Decided: Jul 14, 2019 after 562 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: 2 generations back to K002135 (2000). 2 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112822: Sleepstrip II, S.L.P., Ltd. (2011) Summary page 4.

## Most influential descendants
- K210480: AcuPebble SA (2021), 2 descendants of its own
- K222950: AcuPebble OX100 (2023), 1 descendant of its own
- K243092: AcuPebble Ox (200) (2025), 0 descendants of its own
- K231667: Withings Sleep Rx (2024), 0 descendants of its own
- K213360: SleepCheckRx (2022), 0 descendants of its own

## Indications for use
DROWZLE is indicated to record a patient’s 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. Results are used to assist the healthcare professional in determining the need for further diagnosis and 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/K173974
Methodology: https://510kreport.com/methodology