510(k) · Cleared
ClearedSomryst
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pear Therapeutics, Inc. · QVO Computerized Behavioral Therapy Device For Insomnia
Cleared on Mar 23, 2020 as substantially equivalent to DEN160018 (Pear Therapeutics, Inc., 2017) after a 271-day review. Its family tree reaches back 1 generation to 2017. 3 later devices descend from it.
- Decided
- Mar 23, 2020
- Review
- 271 days
- Class
- Class II
- Product code
- QVO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN160018 (2017). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backDEN160018 reSetPear Therapeutics, Inc. · 2017
- This deviceK191716 SomrystPear Therapeutics, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK233872 DaylightBig Health, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK233577 Sleepio®Big Health, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK223515 MamaLift PlusCurio Digital Therapeutics, Inc. · 2024
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN160018 | reSet | Pear Therapeutics, Inc. | 2017 | — |
| 0 (this device) | K191716 | Somryst | Pear Therapeutics, Inc. | 2020 | — |
| +1 | K233872 | Daylight | Big Health, Inc. | 2024 | — |
| +1 | K233577 | Sleepio® | Big Health, Inc. | 2024 | — |
| +1 | K223515 | MamaLift Plus | Curio Digital Therapeutics, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QVO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QVO device
- #1 K233577 Sleepio®score 8.1 · 2 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN160018 | reSetSummary page 5…ss II Product Code QVO 3. PREDICATE DEVICE Sponsor Pear Therapeutics, Inc. Product reSET® Regulatory Filing DEN160018 Somryst 510(k) Pear Therapeutics, Inc. Somryst Traditional 510(k) P… | 2017 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All QVO devicesQVO Computerized Behavioral Therapy Device For Insomnia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · QVO
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QVO
Too few QVO 510(k)s in any year since 2007 to give a median.
Recalls per year · QVO
No recall names QVO since 2007.
Adverse event reports per year · QVO
1in 2023
MAUDE reports naming product code QVO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191716 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191716: Somryst.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191716
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026