# DEN200029: Parallel

- Pathway: De Novo (Direct)
- Applicant: Mahana Therapeutics, Inc.
- Decided: Nov 25, 2020 after 209 days
- Product code: QMY (Computerized Behavioral Therapy Device For Treating Symptoms)
- Device class: 2
- Regulation: 21 CFR 876.5960
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K211463: Regulora (2021), 0 descendants of its own
- K211372: Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS) (2021), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/DEN200029
Methodology: https://510kreport.com/methodology