510(k) · Cleared
ClearedOstom-I Alert
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
11 Health and Technologies, LLC · EXB Collector, Ostomy
Cleared on Oct 10, 2014 as substantially equivalent to K813269 (Hollister, Inc., 1981) after a 182-day review. Its family tree reaches back 1 generation to 1981. 2 later devices descend from it.
- Decided
- Oct 10, 2014
- Review
- 182 days
- Class
- Class I
- Product code
- EXB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K813269 (1981). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK813269 Two Piece Ostomy SystemHollister, Inc. · 1981
- This deviceK140938 Ostom-I Alert11 Health and Technologies, LLC · 2014
- Descendant · cites it directly · 0 of its ownK252140 Heylo™ SystemColoplast Corp. · 2025
- Descendant · cites it directly · 0 of its ownK181643 SmartBag (SmartPouch)11 Health Technologies Limited · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K813269 | Two Piece Ostomy System | Hollister, Inc. | 1981 | — |
| 0 (this device) | K140938 | Ostom-I Alert | 11 Health and Technologies, LLC | 2014 | — |
| +1 | K252140 | Heylo™ System | Coloplast Corp. | 2025 | — |
| +1 | K181643 | SmartBag (SmartPouch) | 11 Health Technologies Limited | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2025 | 1 | 0 |
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.
Top candidate predicates for a new EXB device
- #1 K252140 Heylo™ Systemscore 10.4 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K813269 | Two Piece Ostomy SystemSummary page 5…807.92(a)(3) Legally Marketed Equivalent Device K Number Product Name Manufacturer K813269 Two Piece Ostomy System Hollister, Inc DEVICE DESCRIPTION… | 1981 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has no recall.
- Of its descendants, K252140 (Coloplast Corp., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All EXB devicesEXB Collector, Ostomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
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…
Read the full statement (130 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K140938 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140938: Ostom-I Alert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140938
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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