# K140938: Ostom-I Alert

- Pathway: 510(k) (Traditional)
- Applicant: 11 Health and Technologies, LLC
- Decided: Oct 10, 2014 after 182 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
Longest line of descent: 1 generation back to K813269 (1981). 1 ancestor in all.
2 later devices descend from it; 2 cite 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)
- K813269: Two Piece Ostomy System, Hollister, Inc. (1981) Summary page 5.

## Most influential descendants
- K252140: Heylo™ System (2025), 0 descendants of its own
- K181643: SmartBag (SmartPouch) (2018), 0 descendants of its own

## Indications for use
The OSTOM-i™ Alert is intended to be used as an accessory to any ostomy bag by monitoring the filling of the bag which information is sent via Bluetooth to a tablet computer to warn healthcare personnel when a patient's bag is close to being full. The Tablet computer automatically captures the data as to the volume and timing of output for each patient. The OSTOM-i™ Alert is indicated for all patient populations. The sensor-based OSTOM-i™ Alert attaches to any ostomy bag and is able to send messages via Bluetooth to a mobile app to warn patient when ostomy bag is close to being full. The sensor-based OSTOM-i™ Alert is intended to be used by the patient outside of the hospital environment. The OSTOM-i™ Alert is indicated for all patient populations.

Source page: https://510kreport.com/device/K140938
Methodology: https://510kreport.com/methodology