# K813526: Fecal Sanitary Tube

- Pathway: 510(k) (Traditional)
- Applicant: Leon'S Fecal Sanitary Tub Mfg.
- Decided: Jan 12, 1982 after 27 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
No predicates in its family tree.
27 later devices descend from it; 2 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K012113: Indwelling Fecal Management System (2002), 26 descendants of its own
- K023344: Indwelling Fecal Management System-Non-Sterile (2002), 16 descendants of its own
- K032734: Convatec Fecal Management System (2004), 14 descendants of its own
- K112342: Flexi-Seal Signal Fecal Management System (2012), 8 descendants of its own
- K083153: Actiflo Indwelling Bowel Catheter System Kit, Models: 32004, 32005, 32006, 32007 (2009), 7 descendants of its own

Source page: https://510kreport.com/device/K813526
Methodology: https://510kreport.com/methodology