Cleared Traditional

K243367 - Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle) (FDA 510(k) Clearance)

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

K243367 · Minnesota Medical Technologies · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2025
Decision
265d
Days
Class 2
Risk

K243367 is an FDA 510(k) clearance for the Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle). Classified as Rectal Insert (product code PBP), Class II - Special Controls.

Submitted by Minnesota Medical Technologies (Stewartville, US). The FDA issued a Cleared decision on July 22, 2025 after a review of 265 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - 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 Minnesota Medical Technologies devices

Submission Details

510(k) Number K243367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2024
Decision Date July 22, 2025
Days to Decision 265 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
135d slower than avg
Panel avg: 130d · This submission: 265d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code PBP Rectal Insert
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
Definition Acts As A Barrier To The Passage Of Fecal Matter Through The Rectum.
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.

Regulatory Consultant

Sachs & Associates, Inc.
Gregory Sachs

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT03934463 Completed Interventional Industry-sponsored

Effects of an Anal Insert Device in Fecal Incontinence

Effects of the Minnesota Medical Technologies Anal Insert Device in Fecal Incontinence

124
Patients (actual)
1
Site
Treatment
Purpose
Open label
Masking
Condition studied Fecal Incontinence
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Adil E Bharucha, MD
Sponsor Minnesota Medical Technologies (industry)
Started 2019-05-16 → Primary completion 2024-02-20
Primary outcome
Primary Effectiveness Endpoint
View full study on ClinicalTrials.gov