510(k) DEN250043
DEN250043 is an FDA 510(k) premarket notification submitted by Cm Technologies, Inc. for the device "Qoramatic Automated Stool Management". The FDA issued a decision of De Novo Granted on Aug 20, 2026. The device falls under product code SJB (Powered Fecal Management System), a Class II device regulated under 21 CFR 876.5230. Cm Technologies, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- Aug 20, 2026
- Date Received
- Sep 15, 2025
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Powered Fecal Management System
- Device Class
- Class II
- Regulation Number
- 876.5230
- Review Panel
- GU
- Submission Type
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 waste transfer, and receptacles for fecal waste containment.