DeviceClearance

Product code SJB— Gastroenterology, Urology

Qoramatic Automated Stool Management

Classification name
Powered Fecal Management System
Device class
Class 2
Regulation
21 CFR 876.5230
Advisory panel
Gastroenterology, Urology
Total cleared
1
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code SJB under 21 CFR 876.5230, via openFDA

Market context for product code SJB

FDA has cleared 1 device under product code SJB, all in 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SJB

Recent clearances under product code SJB

Data sourced from openFDA. This site is unofficial and independent of the FDA.