510(k) · Cleared
ClearedSmartBag (SmartPouch)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
11 Health Technologies Limited · EXB Collector, Ostomy
Cleared on Nov 16, 2018 as substantially equivalent to K140938 (11 Health and Technologies, LLC, 2014) and 1 other predicate after a 147-day review. Its family tree reaches back 2 generations to 1981.
- Decided
- Nov 16, 2018
- Review
- 147 days
- Class
- Class I
- Product code
- EXB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K813269 (1981). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K813269 | Two Piece Ostomy System | Hollister, Inc. | 1981 | — |
| −1 | K140938 | Ostom-I Alert | 11 Health and Technologies, LLC | 2014 | — |
| 0 (this device) | K181643 | SmartBag (SmartPouch) | 11 Health Technologies Limited | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2015 | 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? (2)
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 4…807.92(a)(3) Legally Marketed Equivalent Device K Number Product Name Manufacturer K140938 Alfred Alert 11 Health and Technologies Limited REFERENCE DEVICE Legally Marketed Refere… | 2014 |
| * | K150457 | AlfaSight 9000 Thermographic SystemSummary page 4…11 Health and Technologies Limited REFERENCE DEVICE Legally Marketed Reference Device K Number Product Name Manufacturer K150457 AlfaSight 9000 Thermographic System Alfa Thermodiagnostics, Inc. Our reference device (Alfasight 9000TM) sugges… | 2015 |
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 37 years and passes through 3 companies; a new generation was cleared every 32.9 years on median.
- None of the 4 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. 2018, 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?
SmartBag is intended for use inside and out of hospitals for any patient with a diversionary urinary or fecal stoma. It works in conjunction with 11 Health’s care management platform known as Alfred. The SmartBag system uses integrated sensors to continuously monitor bag filling and drainage, providing cumulative output data to the patient and clinical team. The system also monitors skin condition, the occurrence of leaks and visual condition of the…
Read the full statement (146 words)
SmartBag is intended for use inside and out of hospitals for any patient with a diversionary urinary or fecal stoma. It works in conjunction with 11 Health’s care management platform known as Alfred. The SmartBag system uses integrated sensors to continuously monitor bag filling and drainage, providing cumulative output data to the patient and clinical team. The system also monitors skin condition, the occurrence of leaks and visual condition of the stoma.
SmartBag's intended use is to help ostomates acclimate to their lifestyle. It works in conjunction with 11 Health's care management platform known as Alfred, designed for patients and medical professionals. The SmartBag system (including the wafer and Hub), offers a continuous ostomy monitoring system, tracks the estimated volumetric filling of the bag and visual condition of the stoma using integrated sensor technology.
The SmartBag Sytem is for adult use only. (22 years and above)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181643 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181643: SmartBag (SmartPouch).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181643
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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