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The Tracker / August 2026 / DEN250043

510(k) cleared

Qoramatic Automated Stool Management

Cm Technologies, Inc. · Aug 20, 2026 · DEN250043

FDA cleared the Qoramatic Automated Stool Management from Cm Technologies, Inc. on Aug 20, 2026 under DEN250043, a direct 510(k). The device falls under product code SJB, Powered Fecal Management System, regulated at 21 CFR 876.5230 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Sep 15, 2025. The decision came 339 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Cm Technologies, Inc. has 8 other decisions in the tracker over the last 12 months: K261500 (KBA3D (v2.4.0)), K253808 (AIR Recon DL), K253667 (Accoat Guide Wire), K254130 (C.A. Medical Interbody Fusion System).

Questions & Answers

What did FDA clear under DEN250043?

DEN250043 is the FDA 510(k) for Qoramatic Automated Stool Management, submitted by Cm Technologies, Inc.. FDA's decision date was Aug 20, 2026, under product code SJB (Powered Fecal Management System).

Who makes the Qoramatic Automated Stool Management?

Cm Technologies, Inc., based in Carrollton, TX, is the applicant of record for DEN250043.

How long did the DEN250043 review take?

FDA received the submission on Sep 15, 2025 and issued its decision on Aug 20, 2026, 339 days later.

← All decisions in August 2026