# K243228: Flexi-Seal AIR (with ENFit Connector)

- Pathway: 510(k) (Traditional)
- Applicant: Convatec
- Decided: Mar 28, 2025 after 171 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). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190114: Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector), Convatec Limited (2019) Summary page 5.

## Indications for use
Flexi-Seal AIR™ (with ENFit™ Connector) is an indwelling fecal management catheter intended to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medications. The device is intended for use in adult patients.

Source page: https://510kreport.com/device/K243228
Methodology: https://510kreport.com/methodology