# K191031: NightOwl

- Pathway: 510(k) (Traditional)
- Applicant: Ectosense NV
- Decided: Mar 6, 2020 after 323 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: 8 generations back to K913396 (1992). 48 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161579: Watch-PAT200U, Itamar Medical, Ltd. (2017) Summary page 5.

## Most influential descendants
- K213463: NightOwl (2021), 3 descendants of its own
- K220028: NightOwl (2022), 2 descendants of its own
- K242224: Happy Health Home Sleep Test (2025), 0 descendants of its own
- K243268: TipTraQ (TTQ001) (2025), 0 descendants of its own
- K222579: Belun Sleep System BLS-100 (2023), 0 descendants of its own

## Indications for use
The NightOwl is a wearable device intended for use in the recording, analysis, displaying, exporting, and storage of biophysical parameters to aid in the evaluation of sleep-related breathing disorders of adult patients suspected of sleep apnea. The device is intended for the clinical and home setting use under the direction of a Healthcare Professional (HCP).

Source page: https://510kreport.com/device/K191031
Methodology: https://510kreport.com/methodology