510(k) · Cleared
ClearedMahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS)
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
Cleared on Jun 2, 2021 as substantially equivalent to DEN200029 (Mahana Therapeutics, Inc., 2020) after a 29-day review. Its family tree reaches back 1 generation to 2020.
- Decided
- Jun 2, 2021
- Review
- 29 days
- Class
- Class II
- Product code
- QMY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN200029 (2020). No later device cites it as a predicate yet.
- Root · 1 generation backDEN200029 ParallelMahana Therapeutics, Inc. · 2020
- This deviceK211372 Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile…Mahana Therapeutics, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN200029 | Parallel | Mahana Therapeutics, Inc. | 2020 | — |
| 0 (this device) | K211372 | Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application… | Mahana Therapeutics, Inc. | 2021 | — |
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 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
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 |
|---|---|---|---|
| * | DEN200029 | ParallelSummary page 4…Computerized behavioral therapy device for treating symptoms of gastrointestinal conditions Predicate Device Parallel - DEN200029 Regulation Number 21 CFR 876.5960 Product Code QMY Device Regulation Panel: Gastrointe… | 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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate DEN200029.
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. 2021, 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 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K211372 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211372: Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211372
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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