510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN250043Unknown

Qoramatic Automated Stool Management

Cm Technologies, Inc., Carrollton TX / Direct, Unknown
FDA source (opens on fda.gov)

DEN250043 is the FDA 510(k) clearance record for Qoramatic Automated Stool Management, a class II device, cleared for Cm Technologies, Inc. on under FDA product code SJB (Powered Fecal Management System). FDA's definition for product code SJB reads: "A powered fecal management system is a device that uses powered components to partially or fully divert and contain fecal waste away from a bed-ridden patient. This classification includes accessories such as filters, conduits for fecal...". As of , FDA records show no recalls naming DEN250043.

Clearance record

Decision date
Received
(339 days to decision)
Product code
SJB Powered Fecal Management System
Regulation
21 CFR 876.5230
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Cm Technologies, Inc. 1321 Valwood Pkwy., Carrollton TX
Third party review
No

Clearances, product code SJB

Trailing 12 months
1 clearance under product code SJB in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SJB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260