# K193325: Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches

- Pathway: 510(k) (Traditional)
- Applicant: Prosys International, Ltd.
- Decided: Mar 13, 2020 after 102 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: 5 generations back to K813526 (1982). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150350: Flexi-Seal Signal Fecal Management System, Convatec, Ltd. (2015) Summary page 4.

## Indications for use
The Avantgarde Faecal Management System (FMS) is intended for faecal management by the collection of semi liquid or liquid faecal matter in bedridden adults.

Source page: https://510kreport.com/device/K193325
Methodology: https://510kreport.com/methodology