510(k) · Cleared
ClearedIndwelling Fecal Management System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bowel Management Systems, LLC · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on May 3, 2002 as substantially equivalent to K841289 (Hdc Corp., 1984) and 1 other predicate after a 301-day review. Its family tree reaches back 1 generation to 1982. 26 later devices descend from it.
- Decided
- May 3, 2002
- Review
- 301 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K813526 (1982). 2 ancestors in all. 26 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK813526 Fecal Sanitary TubeLeon'S Fecal Sanitary Tub Mfg. · 1982
- This deviceK012113 Indwelling Fecal Management SystemBowel Management Systems, LLC · 2002
- Descendant · cites it directly · 16 of its ownK023344 Indwelling Fecal Management System-Non-SterileBowel Management Systems, LLC · 2002
- Descendant · cites it directly · 14 of its ownK032734 Convatec Fecal Management SystemConvatec, A Bristol-Myers Squibb Co. · 2004 · Recalled
- Descendant · cites it directly · 8 of its ownK112342 Flexi-Seal Signal Fecal Management SystemConvatec, Inc. · 2012
- Descendant · cites it directly · 7 of its ownK083153 Actiflo Indwelling Bowel Catheter System Kit, Models: 32004, 32005…Hollister, Inc. · 2009
- Descendant · 2 generations on · 6 of its ownK150350 Flexi-Seal Signal Fecal Management SystemConvatec, Ltd. · 2015
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K023344Indwelling Fecal Management System-Non-SterileBowel Management Systems, LLC · 2002 · cites it directly16descendants
- K032734Convatec Fecal Management SystemConvatec, A Bristol-Myers Squibb Co. · 2004 · cites it directly14descendants
- K112342Flexi-Seal Signal Fecal Management SystemConvatec, Inc. · 2012 · cites it directly8descendants
- K083153Actiflo Indwelling Bowel Catheter System Kit, Models: 32004, 32005, 32006, 32007Hollister, Inc. · 2009 · cites it directly7descendants
- K150350Flexi-Seal Signal Fecal Management SystemConvatec, Ltd. · 2015 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K813526 | Fecal Sanitary Tube | Leon'S Fecal Sanitary Tub Mfg. | 1982 | — |
| 0 (this device) | K012113 | Indwelling Fecal Management System | Bowel Management Systems, LLC | 2002 | — |
| +1 | K023344 | Indwelling Fecal Management System-Non-Sterile | Bowel Management Systems, LLC | 2002 | — |
| +1 | K032734 | Convatec Fecal Management System | Convatec, A Bristol-Myers Squibb Co. | 2004 | 3 |
| +1 | K112342 | Flexi-Seal Signal Fecal Management System | Convatec, Inc. | 2012 | — |
| +1 | K083153 | Actiflo Indwelling Bowel Catheter System Kit, Models: 32004, 32005, 32006, 32007 | Hollister, Inc. | 2009 | — |
| +2 | K150350 | Flexi-Seal Signal Fecal Management System | Convatec, Ltd. | 2015 | — |
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 |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K841289 | Rectal Irrigation TubeSummary page 1…S) Common Name: Rectal Irrigation tube Classification Name(s): Tubes, Gastrointestinal Classification Number: 78KNT 807.92(a)(3) Predicate Device(s) HDC Colo-Vage System K841289 Leon’s Fecal Sanitary Tube Manufacture Leon’s Fecal Sanitary Tube K813526 Bard Virden Rectal Catheter Exempt per 21CFR 876.5980 '… | 1984 |
| * | K813526 | Fecal Sanitary TubeSummary page 1…rointestinal Classification Number: 78KNT 807.92(a)(3) Predicate Device(s) HDC Colo-Vage System K841289 Leon’s Fecal Sanitary Tube Manufacture Leon’s Fecal Sanitary Tube K813526 Bard Virden Rectal Catheter Exempt per 21CFR 876.5980 ' (barium enema retention catheter) Additional Substantial Equivalence Inf… | 1982 |
| * | — | Bard Virden Rectal Catheter Named without a submission number |
What descends from it? (26)
See all 264 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?
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?
Diversion of fecal matter to minimize external contact with the patient, to facilitate the collection of fecal matter for patients requiring stool management, and to provide access for colonic irrigation to trigger a defecatory response, and administration of enemas/medications.
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/K012113 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012113: Indwelling 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/K012113
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026