Not Cleared Direct

DEN250043 - Qoramatic Automated Stool Management

DEN250043 · Cm Technologies, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
339d
Days
-
Risk

DEN250043 is an FDA 510(k) submission (not cleared) for the Qoramatic Automated Stool Management.

Submitted by Cm Technologies, Inc. (Carrollton, US). The FDA issued a Not Cleared (DENG) decision on August 20, 2026 after a review of 339 days.

This device falls under the Gastroenterology & Urology FDA review panel. 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 339 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 Cm Technologies, Inc. devices

FDA 510(k) Submission Details - DEN250043

510(k) Number DEN250043 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received September 15, 2025
Decision Date August 20, 2026
Days to Decision 339 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
208d slower than avg
Panel avg: 131d · This submission: 339d
Pathway characteristics

SJB Device Classification - Class ,

Product Code SJB
Device Class -