Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart F — Therapeutic Devices](/submissions/GU/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 876.5230](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/876.5230) → SJB — Powered Fecal Management System

# SJB · Powered Fecal Management System

_Gastroenterology, Urology · 21 CFR 876.5230 · Class 2_

**Canonical URL:** https://fda.innolitics.com/productcode/SJB

## Overview

- **Product Code:** SJB
- **Device Name:** Powered Fecal Management System
- **Regulation:** [21 CFR 876.5230](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/876.5230)
- **Device Class:** 2
- **Review Panel:** [Gastroenterology, Urology](/submissions/GU)

## Identification

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. 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.

## Classification Rationale

FDA concludes that this device should be classified into Class II. This order, therefore, classifies the Qoramatic Automated Stool Management, and substantially equivalent devices of this generic type, into Class II under the generic name powered fecal management system. FDA has determined that, for the previously stated indications for use, the Qoramatic Automated Stool Management can be classified in class II with the establishment of special controls for class II. FDA believes that class II (special) controls provide reasonable assurance of the safety and effectiveness of the device type.

## Special Controls

In combination with the general controls of the FD&C Act, the powered fecal management system is subject to the following special controls:

(1) Clinical performance data must demonstrate that the device performs as intended under its anticipated conditions of use in all intended use environments. Data must include:

(i) Records of powered device operation over the duration of clinical use;
(ii) Device failures; and
(iii) All adverse events, including fecal leakage and any adverse events during insertion, operation, and withdrawal of the device.

(2) Non-clinical performance testing must demonstrate that the device performs as intended under its anticipated conditions of use and all intended use environments. The testing must include:

(i) Simulated testing of fecal waste diversion and containment with powered functions for the expected duration of use; and
(ii) Evaluation of pressures exerted on and within the rectum during insertion, operation, and withdrawal of the device over the intended duration of use.

(3) The patient-contacting components of the device must be demonstrated to be biocompatible.

(4) Software verification, validation, and hazard analysis must be performed.

(5) Performance data must demonstrate the electromagnetic compatibility, electrical safety, and mechanical safety of the device.

(6) Performance data must support the shelf life of the device by demonstrating continued package integrity and device functionality over the labeled shelf life.

(7) Labeling must include:

(i) Intended duration of use for the device;
(ii) Information on each powered function, including how operators can monitor and control any powered function; and
(iii) A summary of the clinical data pertinent to use of the device, including device-related complications or adverse events.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [DEN250043](/device/DEN250043.md) | Qoramatic Automated Stool Management | Cm Technologies, Inc. | Aug 20, 2026 | DENG |

## Top Applicants

- Cm Technologies, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/productcode/SJB](https://fda.innolitics.com/productcode/SJB)

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