510(k) · Cleared
ClearedHeylo™ System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coloplast Corp. · EXB Collector, Ostomy
Cleared on Oct 6, 2025 as substantially equivalent to K140938 (11 Health and Technologies, LLC, 2014) after a 90-day review. Its family tree reaches back 2 generations to 1981.
- Decided
- Oct 6, 2025
- Review
- 90 days
- Class
- Class I
- Product code
- EXB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K813269 (1981). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EXB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K140938 | Ostom-I AlertSummary page 5…logy-Urology III. PREDICATE DEVICE Primary Predicate: Ostom-I Alert 510(k) Holder: 11 HEALTH AND TECHNOLOGIES LLC 510(k) Number: K140938 K252140… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 44 years and passes through 3 companies; a new generation was cleared every 32.9 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K140938.
How does its category compare?
All EXB devicesEXB Collector, Ostomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · EXB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EXB
Too few EXB 510(k)s in any year since 2007 to give a median.
Recalls per year · EXB
3in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EXB
20in 2025
MAUDE reports naming product code EXB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 2 | 1 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 5 |
| 2011 | 0 | — | 3 | 4 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 0 | — | 0 | 187 |
| 2014 | 1 | — | 0 | 55 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 0 | — | 0 | 20 |
| 2017 | 0 | — | 0 | 20 |
| 2018 | 1 | — | 0 | 36 |
| 2019 | 0 | — | 0 | 34 |
| 2020 | 0 | — | 0 | 22 |
| 2021 | 0 | — | 0 | 42 |
| 2022 | 0 | — | 0 | 36 |
| 2023 | 0 | — | 0 | 11 |
| 2024 | 0 | — | 0 | 13 |
| 2025 | 1 | — | 0 | 20 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252140 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252140: Heylo™ System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252140
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026