510(k) · Cleared
ClearedSleepio®
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Big Health, Inc. · QVO Computerized Behavioral Therapy Device For Insomnia
Cleared on Aug 5, 2024 as substantially equivalent to K191716 (Pear Therapeutics, Inc., 2020) after a 272-day review. Its family tree reaches back 2 generations to 2017.
- Decided
- Aug 5, 2024
- Review
- 272 days
- Class
- Class II
- Product code
- QVO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN160018 (2017). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 K191716 Somrystscore 8.1 · 1 generation · 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 |
|---|---|---|---|
| * | K191716 | SomrystSummary page 4…Psychiatry Disorders (21 CFR 882.5801) Regulatory class: Class II (Special Controls) 510(k) Number: K191716 Product code: QVO 4. Device Description Sleepio is a digital therapeutic for the treatment of chroni… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 4.4 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K191716.
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. 2024, 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?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K233577 · printed Nov 4, 2026
Cite this page
510(k) Report. “K233577: Sleepio®.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K233577
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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