Cleared Traditional

K233974 - Mucosal Impedance Measurement System (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K233974 · Alandra Medical Sapi DE CV · Gastroenterology & Urology device
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Sep 2024
Decision
266d
Days
Class 2
Risk

K233974 is an FDA 510(k) clearance for the Mucosal Impedance Measurement System. Classified as Esophageal, Mucosal, Electrical Characterization (product code QIS), Class II - Special Controls.

Submitted by Alandra Medical Sapi DE CV (Mexico City, MX). The FDA issued a Cleared decision on September 6, 2024 after a review of 266 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1450 - 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 Alandra Medical Sapi DE CV devices

Submission Details

510(k) Number K233974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2023
Decision Date September 06, 2024
Days to Decision 266 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
136d slower than avg
Panel avg: 130d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QIS Esophageal, Mucosal, Electrical Characterization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1450
Definition The Esophageal Tissue Characterization System Is Intended For Obtaining Measurements Of Electrical Properties Within Esophageal Tissue.
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.

Regulatory Consultant

Hogan Lovells US LLP
Randy Prebula

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.