Cleared Traditional

K211463 - Regulora (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence.

K211463 · Metame Health, Inc. · Gastroenterology & Urology device
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Nov 2021
Decision
197d
Days
Class 2
Risk

K211463 is an FDA 510(k) clearance for the Regulora. Classified as Computerized Behavioral Therapy Device For Treating Symptoms (product code QMY), Class II - Special Controls.

Submitted by Metame Health, Inc. (Chicago, US). The FDA issued a Cleared decision on November 24, 2021 after a review of 197 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5960 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Metame Health, Inc. devices

Submission Details

510(k) Number K211463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2021
Decision Date November 24, 2021
Days to Decision 197 days
Submission Type Traditional
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
67d slower than avg
Panel avg: 130d · This submission: 197d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Gastroenterology & Urology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT04133519 Completed Interventional Industry-sponsored

Efficacy and Safety of IBS Digital Behavioral Treatment

The Efficacy and Safety of IBS Digital Behavioral Treatment Study

378
Patients (actual)
1
Site
Treatment
Purpose
Triple
Masking
Condition studied Irritable Bowel Syndrome
Study design Parallel
Eligibility All sexes · 18 Years+
Principal investigator Lucy Pun, DO
Sponsor metaMe Health (industry)
Started 2019-10-23 → Primary completion 2020-10-28 → Completed 2021-10-26
Primary outcome
Abdominal Pain Intensity Responder
Secondary outcome
Abdominal Pain Intensity
View full study on ClinicalTrials.gov