# K212444: Qora Stool Management Kit

- Pathway: 510(k) (Special)
- Applicant: Cm Technologies, Inc.
- Decided: Nov 17, 2021 after 104 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K813526 (1982). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153506: Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit, Consure Medical Pvt, Ltd. (2016) Summary page 4.

## Indications for use
The Qora® Stool Management Kit is indicated for fecal management by diverting and collecting liquid or semi-formed stool to minimize skin contact with bedridden patients. The device is for use in patients 18 years and older only. The uninterrupted use of this device, including replacement with other same devices, should not exceed 29 days.

Source page: https://510kreport.com/device/K212444
Methodology: https://510kreport.com/methodology