Not Cleared Direct

DEN210032 - AccuMeasure System (FDA 510(k) Clearance)

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

DEN210032 · RQMIS, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2022
Decision
351d
Days
Class 2
Risk

DEN210032 is an FDA 510(k) submission (not cleared) for the AccuMeasure System. Classified as Endoscopic Light-projecting Measuring Device (product code QTH), Class II - Special Controls.

Submitted by RQMIS, Inc. (Amesbury, US). The FDA issued a Not Cleared (DENG) decision on July 26, 2022 after a review of 351 days.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1530 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 351 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all RQMIS, Inc. devices

Submission Details

510(k) Number DEN210032 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received August 09, 2021
Decision Date July 26, 2022
Days to Decision 351 days
Submission Type Direct
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
221d slower than avg
Panel avg: 130d · This submission: 351d
Pathway characteristics

Device Classification

Product Code QTH Endoscopic Light-projecting Measuring Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1530
Definition An Endoscopic Light-projecting Measuring Device Projects Light On A Mucosal Surface And Uses Software To Determine The Dimensions Of Observable Features Of Interest.
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.