# DEN250043: Qoramatic Automated Stool Management

- Pathway: De Novo (Direct)
- Applicant: Cm Technologies, Inc.
- Decided: Aug 20, 2026 after 339 days
- Product code: SJB (Powered Fecal Management System)
- Device class: 2
- Regulation: 21 CFR 876.5230
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The Qoramatic Automated Stool Management device is intended for fecal management by diverting and collecting liquid or semi-liquid stool to minimize skin contact in bedridden patients. Adults use only.

Source page: https://510kreport.com/device/DEN250043
Methodology: https://510kreport.com/methodology