De Novo · Granted
GrantedParallel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mahana Therapeutics, Inc. · QMY Computerized Behavioral Therapy Device For Treating Symptoms
Granted on Nov 25, 2020 as a new device type through De Novo after a 209-day review. 2 later devices descend from it.
- Decided
- Nov 25, 2020
- Review
- 209 days
- Class
- Class II
- Product code
- QMY
- Recalls
- None
2 later devices descend from it, 2 citing it directly.
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN200029 | Parallel | Mahana Therapeutics, Inc. | 2020 | — |
| +1 | K211463 | Regulora | Metame Health, Inc. | 2021 | — |
| +1 | K211372 | Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application… | Mahana Therapeutics, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
Sources: FDA De Novo 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 QMY? 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 QMY device
- #1 K211463 Regulorascore 2.4 · 1 generation · no Class I recall
- #2 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (2)
2 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?
- Of its descendants, K211463 (Metame Health, Inc., 2021) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QMY devicesQMY Computerized Behavioral Therapy Device For Treating Symptoms: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · QMY
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · QMY
Too few QMY 510(k)s in any year since 2007 to give a median.
Recalls per year · QMY
No recall names QMY since 2007.
Adverse event reports per year · QMY
No MAUDE report names QMY since 2007.
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 | 2 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Parallel is a prescription-only digital therapeutic device intended to provide cognitive behavioral therapy for adults aged 22 years of age and older who have been diagnosed with Irritable Bowel Syndrome (IBS). Parallel is indicated as a 3 month treatment for patients with IBS. Parallel treats IBS by reducing the severity of symptoms and is intended to be used together with other IBS treatments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN200029 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN200029: Parallel.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN200029
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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