# K191716: Somryst

- Pathway: 510(k) (Traditional)
- Applicant: Pear Therapeutics, Inc.
- Decided: Mar 23, 2020 after 271 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: 1 generation back to DEN160018 (2017). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN160018: reSet, Pear Therapeutics, Inc. (2017) Summary page 5.

## Most influential descendants
- K233872: Daylight (2024), 0 descendants of its own
- K233577: Sleepio® (2024), 0 descendants of its own
- K223515: MamaLift Plus (2024), 0 descendants of its own

## Indications for use
Somryst is a prescription-only digital therapeutic intended to provide a neurobehavioral intervention (Cognitive Behavioral Therapy for Insomnia – CBT-I) in patients 22 years of age and older with chronic insomnia. Somryst treats chronic insomnia by improving a patient’s insomnia symptoms.

Source page: https://510kreport.com/device/K191716
Methodology: https://510kreport.com/methodology