510(k) · Cleared
ClearedRegulora
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Metame Health, Inc. · QMY Computerized Behavioral Therapy Device For Treating Symptoms
Cleared on Nov 24, 2021 as substantially equivalent to DEN200029 (Mahana Therapeutics, Inc., 2020) after a 197-day review. Its family tree reaches back 1 generation to 2020.
- Decided
- Nov 24, 2021
- Review
- 197 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 deviceK211463 ReguloraMetame Health, 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) | K211463 | Regulora | Metame Health, 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 K211372 Mahana Parallel Digital Cognitive Behavioral…score 1.5 · 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…Classification Name: Computerized behavioral therapy device for treating symptoms Predicate Device: Parallel, DEN200029 Device Description Regulora™ is prescription-only digital therapeutic software indicated for use in the treatment of abdominal p… | 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?
Regulora™ is a prescription-only digital therapeutic device intended to provide behavioral therapy through gut-directed hypnotherapy for adults 22 years of age and older who have been diagnosed with Irritable Bowel Syndrome (IBS). Regulora is indicated as a 3-month treatment for patients with abdominal pain due to IBS 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/K211463 · printed Nov 3, 2026
Cite this page
510(k) Report. “K211463: Regulora.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K211463
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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