Qoramatic Automated Stool Management— 510(k) DEN250043

Name: FDA 510(k) clearance DEN250043
Creator: U.S. Food and Drug Administration
Published: 2026-08-20

Unknown

Cm Technologies, Inc.

FDA 510(k) clearance DEN250043 for Qoramatic Automated Stool Management, Unknown on 2026-08-20. Applicant: Cm Technologies, Inc.. Device class: 2.

Summary

CM Technologies filed the Qoramatic Automated Stool Management under product code SJB, powered fecal management systems. The record gives no model numbers or further description.

Class II, 21 CFR 876.5230. Gastroenterology and Urology is both the classification panel and the review panel. The record lists the submission type as Direct.

CM Technologies filed from Carrollton, Texas. The decision date came 339 calendar days after the received date (September 15, 2025 to August 20, 2026).

Clearance details

Applicant: Cm Technologies, Inc.
Product code: Product code SJB
Device class: Class 2
Regulation: 21 CFR 876.5230
Advisory panel: Gastroenterology, Urology
Date received: 2025-09-15
Decision date: 2026-08-20
Decision: Unknown
Clearance type: Direct
Location: Carrollton, TX, US

View on FDA.gov ↗

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