510(k) · Cleared
ClearedFlexi-Seal Signal Fecal Management System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Convatec, Inc. · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Apr 26, 2012 as substantially equivalent to K032734 (Convatec, A Bristol-Myers Squibb Co., 2004) and 1 other predicate after a 255-day review. Its family tree reaches back 3 generations to 1982. 8 later devices descend from it.
- Decided
- Apr 26, 2012
- Review
- 255 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K813526 (1982). 4 ancestors in all. 8 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK813526 Fecal Sanitary TubeLeon'S Fecal Sanitary Tub Mfg. · 1982
- 2 generations backK012113 Indwelling Fecal Management SystemBowel Management Systems, LLC · 2002
- 1 generation backK032734 Convatec Fecal Management SystemConvatec, A Bristol-Myers Squibb Co. · 2004 · Recalled
- This deviceK112342 Flexi-Seal Signal Fecal Management SystemConvatec, Inc. · 2012
- Descendant · cites it directly · 6 of its ownK150350 Flexi-Seal Signal Fecal Management SystemConvatec, Ltd. · 2015
- Descendant · 2 generations on · 2 of its ownK162906 Flexi-Seal PROTECT Fecal Management SystemConvatec · 2017
- Descendant · 2 generations on · 1 of its ownK221400 hygh-tec drainageCreative Balloons GmbH · 2023
- Descendant · 3 generations on · 1 of its ownK190114 Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)Convatec Limited · 2019
- Descendant · 4 generations on · 0 of its ownK243228 Flexi-Seal AIR (with ENFit Connector)Convatec · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K150350Flexi-Seal Signal Fecal Management SystemConvatec, Ltd. · 2015 · cites it directly6descendants
- K162906Flexi-Seal PROTECT Fecal Management SystemConvatec · 2017 · 2 generations on2descendants
- K221400hygh-tec drainageCreative Balloons GmbH · 2023 · 2 generations on1descendant
- K190114Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)Convatec Limited · 2019 · 3 generations on1descendant
- K243228Flexi-Seal AIR (with ENFit Connector)Convatec · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K813526 | Fecal Sanitary Tube | Leon'S Fecal Sanitary Tub Mfg. | 1982 | — |
| −2 | K012113 | Indwelling Fecal Management System | Bowel Management Systems, LLC | 2002 | — |
| −1 | K032734 | Convatec Fecal Management System | Convatec, A Bristol-Myers Squibb Co. | 2004 | 3 |
| 0 (this device) | K112342 | Flexi-Seal Signal Fecal Management System | Convatec, Inc. | 2012 | — |
| +1 | K150350 | Flexi-Seal Signal Fecal Management System | Convatec, Ltd. | 2015 | — |
| +2 | K162906 | Flexi-Seal PROTECT Fecal Management System | Convatec | 2017 | — |
| +2 | K221400 | hygh-tec drainage | Creative Balloons GmbH | 2023 | — |
| +3 | K190114 | Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector) | Convatec Limited | 2019 | — |
| +4 | K243228 | Flexi-Seal AIR (with ENFit Connector) | Convatec | 2025 | — |
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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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? (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 |
|---|---|---|---|
| * | K032734 | Convatec Fecal Management SystemSummary page 1…ries (ref. 21 CFR 876.5980; Product Code [(NT) Device Class: Class 11 510(k) Substantial Equivalence: K032734 - determined substantially equivalent on April 8, 2004 Trade Name:… | 2004 |
| * | K012113 | Indwelling Fecal Management SystemSummary page 1…ories (ref. 21 CFR 876.5980; Product Code KNT) Device Class: Class If 510(k) Substantial Equivalence: K0121 13 - determined substantially equivalent on May 3,2002… | 2002 |
What descends from it? (8)
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?
- The line of descent spans 30 years and passes through 4 companies; a new generation was cleared every 8.0 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K150350 (Convatec, Ltd., 2015) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K032734.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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 use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112342 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112342: Flexi-Seal Signal 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/K112342
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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