# K112822: Sleepstrip II

- Pathway: 510(k) (Traditional)
- Applicant: S.L.P., Ltd.
- Decided: Dec 27, 2011 after 90 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: 1 generation back to K002135 (2000). 1 ancestor in all.
6 later devices descend from it; 1 cites 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)
- K002135: Sleepstrip Disposable Apnea Screener, Influent, Ltd. (2000) Summary page 1.

## Most influential descendants
- K173974: Drowzle (2019), 5 descendants of its own
- 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

## Indications for use
The SleepStrip I1 is intended to measure apnealhyponea events during sleep for the purpose of prescreening patients for sleep apnea syndrome. The device is intended to be used by adult patients as prescribed by a physician in either home, hospital or facility use settings.

Source page: https://510kreport.com/device/K112822
Methodology: https://510kreport.com/methodology