# K813269: Two Piece Ostomy System

- Pathway: 510(k) (Traditional)
- Applicant: Hollister, Inc.
- Decided: Dec 3, 1981 after 13 days
- Product code: EXB (Collector, Ostomy)
- Device class: 1
- Regulation: 21 CFR 876.5900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 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
- K140938: Ostom-I Alert (2014), 2 descendants of its own
- K252140: Heylo™ System (2025), 0 descendants of its own
- K181643: SmartBag (SmartPouch) (2018), 0 descendants of its own

Source page: https://510kreport.com/device/K813269
Methodology: https://510kreport.com/methodology