# K252140: Heylo™ System

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast Corp.
- Decided: Oct 6, 2025 after 90 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: 2 generations back to K813269 (1981). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140938: Ostom-I Alert, 11 Health and Technologies, LLC (2014) Summary page 5.

## Indications for use
Heylo T M System is indicated to allow detection of ostomy appliance leakage for people with an ileostomy or colostomy, giving them an opportunity to take preventative measures. HeyloTM System is comprised of a protective adhesive barrier with integrated sensors that detect occurrences of leakage of output from the wearer's stoma and a transmitter that translates leakage data and sends notifications to the user's HeyloTM app. HeyloTr System and its components are for individuals with an ostomy 12 years and older.

Source page: https://510kreport.com/device/K252140
Methodology: https://510kreport.com/methodology