# K840568: Active Life One-Piece Closed-End Pouch

- Pathway: 510(k) (Traditional)
- Applicant: Convatec, A Division of E.R. Squibb & Sons
- Decided: May 2, 1984 after 84 days
- Product code: EXB (Collector, Ostomy)
- Device class: 1
- Regulation: 21 CFR 876.5900
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Jul 31, 2006 · Not classified · Z-1531-06: Cartons may contain one or more units that are 1 1/2'' size rather than 1 3/4'' size as indicated on the label.
- Jul 31, 2006 · Not classified · Z-1532-06: Cartons may contain one or more units that are 1 1/2'' size rather than 1 3/4'' size as indicated on the label.

Source page: https://510kreport.com/device/K840568
Methodology: https://510kreport.com/methodology