510(k) · Cleared
Recalled · Class III · 2013Convatec Fecal Management System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Convatec, A Bristol-Myers Squibb Co. · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Apr 8, 2004 as substantially equivalent to K012113 (Bowel Management Systems, LLC, 2002) after a 217-day review. Its family tree reaches back 2 generations to 1982. 14 later devices descend from it. It has been recalled 3 times.
- Decided
- Apr 8, 2004
- Review
- 217 days
- Class
- Class II
- Product code
- KNT
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 2 generations to K813526 (1982). 3 ancestors in all. 14 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK813526 Fecal Sanitary TubeLeon'S Fecal Sanitary Tub Mfg. · 1982
- 1 generation backK012113 Indwelling Fecal Management SystemBowel Management Systems, LLC · 2002
- This deviceK032734 Convatec Fecal Management SystemConvatec, A Bristol-Myers Squibb Co. · 2004
- Descendant · cites it directly · 8 of its ownK112342 Flexi-Seal Signal Fecal Management SystemConvatec, Inc. · 2012
- Descendant · 2 generations on · 6 of its ownK150350 Flexi-Seal Signal Fecal Management SystemConvatec, Ltd. · 2015
- Descendant · cites it directly · 5 of its ownK073598 Bard Dignicare Stool Management SystemC.R. Bard, Inc. · 2008
- Descendant · 2 generations on · 4 of its ownK102391 Bard Dignishield Stool Management SystemC.R. Bard, Inc. · 2010
- Descendant · 3 generations on · 2 of its ownK162906 Flexi-Seal PROTECT Fecal Management SystemConvatec · 2017
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K112342Flexi-Seal Signal Fecal Management SystemConvatec, Inc. · 2012 · cites it directly8descendants
- K150350Flexi-Seal Signal Fecal Management SystemConvatec, Ltd. · 2015 · 2 generations on6descendants
- K073598Bard Dignicare Stool Management SystemC.R. Bard, Inc. · 2008 · cites it directly5descendants
- K102391Bard Dignishield Stool Management SystemC.R. Bard, Inc. · 2010 · 2 generations on4descendants
- K162906Flexi-Seal PROTECT Fecal Management SystemConvatec · 2017 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K813526 | Fecal Sanitary Tube | Leon'S Fecal Sanitary Tub Mfg. | 1982 | — |
| −1 | K012113 | Indwelling Fecal Management System | Bowel Management Systems, LLC | 2002 | — |
| 0 (this device) | K032734 | Convatec Fecal Management System | Convatec, A Bristol-Myers Squibb Co. | 2004 | — |
| +1 | K112342 | Flexi-Seal Signal Fecal Management System | Convatec, Inc. | 2012 | — |
| +2 | K150350 | Flexi-Seal Signal Fecal Management System | Convatec, Ltd. | 2015 | — |
| +1 | K073598 | Bard Dignicare Stool Management System | C.R. Bard, Inc. | 2008 | — |
| +2 | K102391 | Bard Dignishield Stool Management System | C.R. Bard, Inc. | 2010 | — |
| +3 | K162906 | Flexi-Seal PROTECT Fecal Management System | Convatec | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 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 KNT? 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 KNT device
- #1 K261890 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D®score 12.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K012113 | Indwelling Fecal Management System | 2002 |
What descends from it? (14)
See all 142 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 25, 2013 | Class III | Z-1990-2013 | Under Investigation by firm | ConvaTec notified their customers on 6/25/2013 regarding the manufacturing irregularity that occurred related to the packaging of certain lots of Flexi-Seal Signal FMS. In certain lots, the lot number convention was duplicated on the… |
| Jun 25, 2013 | Class III | Z-1991-2013 | Under Investigation by firm | ConvaTec notified their customers on 6/25/2013 regarding the manufacturing irregularity that occurred related to the packaging of certain lots of Flexi-Seal Signal FMS. In certain lots, the lot number convention was duplicated on the… |
| Nov 20, 2008 | Not classified | Z-0618-2009 | Nonconforming Material/Component | It was discovered that a portion of the inner nylon sleeve of the catheter was visible at the balloon end of a sample device. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 20.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K112342 (Convatec, Inc., 2012) has gone furthest, with 8 descendants of its own.
- 3 other devices also cite its predicate K012113.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KNT
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNT
136in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNT
13in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KNT
1,451in 2025
MAUDE reports naming product code KNT, 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 | 10 | 118 | 1 | 300 |
| 2008 | 10 | 115 | 82 | 867 |
| 2009 | 11 | 102 | 9 | 818 |
| 2010 | 12 | 104 | 3 | 517 |
| 2011 | 7 | 211 | 2 | 531 |
| 2012 | 12 | 107 | 1 | 528 |
| 2013 | 7 | 128 | 0 | 747 |
| 2014 | 16 | 259 | 0 | 1,030 |
| 2015 | 10 | 140 | 1 | 1,048 |
| 2016 | 6 | 99 | 3 | 1,251 |
| 2017 | 9 | 247 | 4 | 1,672 |
| 2018 | 7 | 149 | 2 | 1,901 |
| 2019 | 10 | 126 | 2 | 1,838 |
| 2020 | 5 | 102 | 1 | 1,641 |
| 2021 | 6 | 121 | 2 | 1,655 |
| 2022 | 7 | 110 | 1 (1) | 1,650 |
| 2023 | 5 | 162 | 2 | 1,863 |
| 2024 | 9 | 103 | 0 | 1,344 |
| 2025 | 4 | 136 | 13 | 1,451 |
| 2026 | 3 | 105 | 20 | — |
What is it indicated for?
For the fecal management of patients with little or no bowel control and for patients whose stool is semi-liquid or liquid
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032734 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032734: Convatec Fecal Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032734
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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