# K221400: hygh-tec drainage

- Pathway: 510(k) (Traditional)
- Applicant: Creative Balloons GmbH
- Decided: Feb 9, 2023 after 269 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.
1 later device descends from it; 1 cites it directly.
0 of 8 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.

## Most influential descendants
- K242336: hygh-tec Drainage II (2025), 0 descendants of its own

## Indications for use
The hygh-tec drainage is a fecal management system that is intended for continuous, trans-anal drainage and collection of liquid or semi-liquid stools and to provide access for the administration of medications. The device is not intended for use on pediatric patients.

Source page: https://510kreport.com/device/K221400
Methodology: https://510kreport.com/methodology