# K233577: Sleepio®

- Pathway: 510(k) (Traditional)
- Applicant: Big Health, Inc.
- Decided: Aug 5, 2024 after 272 days
- Product code: QVO (Computerized Behavioral Therapy Device For Insomnia)
- Device class: 2
- Regulation: 21 CFR 882.5801
- 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 DEN160018 (2017). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191716: Somryst, Pear Therapeutics, Inc. (2020) Summary page 4.

## Indications for use
Sleepio is a digital therapeutic intended for the treatment of chronic insomnia / insomnia disorder as an adjunct to usual care in patients aged 18 and older. Sleepio is a prescription device delivering Cognitive Behavioral Therapy for Insomnia (CBT-]) and can be made available on the order of a licensed healthcare provider.

Source page: https://510kreport.com/device/K233577
Methodology: https://510kreport.com/methodology