# K220095: ANNE Sleep

- Pathway: 510(k) (Traditional)
- Applicant: Sibel, Inc.
- Decided: Jul 11, 2022 after 180 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: 10 generations back to K913396 (1992). 50 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183559: WatchPAT ONE, Itamar Medical, Ltd. (2019) Summary page 4.

## Most influential descendants
- K240285: Huxley SANSA Home Sleep Apnea Test (1000-00) (2024), 3 descendants of its own
- K244027: Sansa Hsat (2025), 2 descendants of its own
- K253148: RX-1 Sleep (2026), 0 descendants of its own
- K252497: Sansa Hsat (2025), 0 descendants of its own

## Indications for use
ANNE Sleep is a wearable sensor system intended for use in the collection, analysis, display, and storage of physiological parameters to aid in the evaluation of sleep-related breathing disorders of adult patients suspected of sleep apnea. The device is intended for use in the clinical and home setting under the direction and interpretation by a Healthcare Professional (HCP).

Source page: https://510kreport.com/device/K220095
Methodology: https://510kreport.com/methodology