Cleared Special

K211372 - Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS) (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K211372 · Mahana Therapeutics, Inc. · Gastroenterology & Urology device
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Jun 2021
Decision
29d
Days
Class 2
Risk

K211372 is an FDA 510(k) clearance for the Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application.... Classified as Computerized Behavioral Therapy Device For Treating Symptoms (product code QMY), Class II - Special Controls.

Submitted by Mahana Therapeutics, Inc. (San Francisco, US). The FDA issued a Cleared decision on June 2, 2021 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5960 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Mahana Therapeutics, Inc. devices

Submission Details

510(k) Number K211372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2021
Decision Date June 02, 2021
Days to Decision 29 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 130d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code QMY Computerized Behavioral Therapy Device For Treating Symptoms
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5960
Definition A Computerized Behavioral Therapy Device For Treating Symptoms Of Gastrointestinal Conditions Is A Prescription Device Intended To Provide A Computerized Version Of Condition-specific Therapy As An Adjunct To Standard Of Care Treatments To Patients With Gastrointestinal Conditions.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.