510(k) · Cleared
ClearedTwo Piece Ostomy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hollister, Inc. · EXB Collector, Ostomy
Cleared on Dec 3, 1981 after a 13-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Dec 3, 1981
- Review
- 13 days
- Class
- Class I
- Product code
- EXB
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK813269 Two Piece Ostomy SystemHollister, Inc. · 1981
- Descendant · cites it directly · 2 of its ownK140938 Ostom-I Alert11 Health and Technologies, LLC · 2014
- Descendant · 2 generations on · 0 of its ownK252140 Heylo™ SystemColoplast Corp. · 2025
- Descendant · 2 generations on · 0 of its ownK181643 SmartBag (SmartPouch)11 Health Technologies Limited · 2018
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K813269 | Two Piece Ostomy System | Hollister, Inc. | 1981 | — |
| +1 | K140938 | Ostom-I Alert | 11 Health and Technologies, LLC | 2014 | — |
| +2 | K252140 | Heylo™ System | Coloplast Corp. | 2025 | — |
| +2 | K181643 | SmartBag (SmartPouch) | 11 Health Technologies Limited | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140938 | Ostom-I Alert | 2014 | 2 |
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?
- Of its descendants, K140938 (11 Health and Technologies, LLC, 2014) has gone furthest, with 2 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.
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 | — |
https://510kreport.com/device/K813269 · printed Nov 6, 2026
Cite this page
510(k) Report. “K813269: Two Piece Ostomy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K813269
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026