# K153506: Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit

- Pathway: 510(k) (Traditional)
- Applicant: Consure Medical Pvt, Ltd.
- Decided: May 6, 2016 after 151 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: 6 generations back to K813526 (1982). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133465: Consure Stool Management System, Consure Medical Pvt, Ltd. (2014) Summary page 4.

## Most influential descendants
- K212444: Qora Stool Management Kit (2021), 0 descendants of its own

## Indications for use
The Qora AIM™ Stool Management Kit is indicated for fecal management by diverting and collecting liquid or semi-formed stool to minimize skin contact in bedridden patients. The device is for use in patients 18 years and older only. The uninterrupted use for this device, including replacement with other same devices, should not exceed 29 days. The Qora Aeon™ Stool Management Kit is indicated for fecal management by diverting and collecting liquid or semi-formed stool to minimize skin contact in bedridden patients. The device is for use in patients 18 years and older only. The uninterrupted use for this device, including replacement with other same devices, should not exceed 29 days. The Qora Arida™ Stool Management Kit is indicated for fecal management by diverting and collecting liquid or semi-formed stool to minimize skin contact in bedridden patients. The device is for use in patients 18 years and older only. The uninterrupted use for this device is intended to be until the collection pouch is filled or until it has been utilized for 72 hours, whichever comes first. The replacement with other same devices should not exceed 29 days.

Source page: https://510kreport.com/device/K153506
Methodology: https://510kreport.com/methodology