510(k) · Cleared
ClearedIndwelling Fecal Management System-Non-Sterile
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 Nov 6, 2002 as substantially equivalent to K012113 (Bowel Management Systems, LLC, 2002) and 2 other predicates after a 30-day review. Its family tree reaches back 2 generations to 1982. 16 later devices descend from it.
- Decided
- Nov 6, 2002
- Review
- 30 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K813526 (1982). 3 ancestors in all. 16 later devices descend from it, 4 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 deviceK023344 Indwelling Fecal Management System-Non-SterileBowel Management Systems, LLC · 2002
- Descendant · cites it directly · 7 of its ownK083153 Actiflo Indwelling Bowel Catheter System Kit, Models: 32004, 32005…Hollister, Inc. · 2009
- Descendant · cites it directly · 5 of its ownK083770 Coloplast Peristeen Anal Irrigation (Pai) SystemColoplast A/S · 2009
- Descendant · cites it directly · 5 of its ownK073598 Bard Dignicare Stool Management SystemC.R. Bard, Inc. · 2008
- Descendant · 2 generations on · 4 of its ownK103254 Peristeen Anal Irrigation System, Irrigation Accessory Unit…Coloplast A/S · 2011
- Descendant · 2 generations on · 4 of its ownK102391 Bard Dignishield Stool Management SystemC.R. Bard, Inc. · 2010
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K083153Actiflo Indwelling Bowel Catheter System Kit, Models: 32004, 32005, 32006, 32007Hollister, Inc. · 2009 · cites it directly7descendants
- K083770Coloplast Peristeen Anal Irrigation (Pai) SystemColoplast A/S · 2009 · cites it directly5descendants
- K073598Bard Dignicare Stool Management SystemC.R. Bard, Inc. · 2008 · cites it directly5descendants
- K103254Peristeen Anal Irrigation System, Irrigation Accessory Unit, Irrigation Rectal Catheter…Coloplast A/S · 2011 · 2 generations on4descendants
- K102391Bard Dignishield Stool Management SystemC.R. Bard, Inc. · 2010 · 2 generations on4descendants
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) | K023344 | Indwelling Fecal Management System-Non-Sterile | Bowel Management Systems, LLC | 2002 | — |
| +1 | K083153 | Actiflo Indwelling Bowel Catheter System Kit, Models: 32004, 32005, 32006, 32007 | Hollister, Inc. | 2009 | — |
| +1 | K083770 | Coloplast Peristeen Anal Irrigation (Pai) System | Coloplast A/S | 2009 | — |
| +1 | K073598 | Bard Dignicare Stool Management System | C.R. Bard, Inc. | 2008 | — |
| +2 | K103254 | Peristeen Anal Irrigation System, Irrigation Accessory Unit, Irrigation Rectal… | Coloplast A/S | 2011 | — |
| +2 | K102391 | Bard Dignishield Stool Management System | C.R. Bard, Inc. | 2010 | — |
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 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 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 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? (4)
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 SystemSummary page 3…re IFMS -Non Sterile | IFMS Catheter Colo-Vage System | Virden Rectal Fecal Sanitary (Bowel Mgt Sys) (Bowel Mgt Sys) (HDC Corp.) Catheter (Bard) Tube (This Submission) | K012113 K841289 Exempt per (Leon's Fecal Tube 21CFR 876.5980 mfg.) K813526 Indications for Use | Diversion of fecal Diversion of fecal Co… | 2002 |
| * | K841289 | Rectal Irrigation TubeSummary page 3…-Non Sterile | IFMS Catheter Colo-Vage System | Virden Rectal Fecal Sanitary (Bowel Mgt Sys) (Bowel Mgt Sys) (HDC Corp.) Catheter (Bard) Tube (This Submission) | K012113 K841289 Exempt per (Leon's Fecal Tube 21CFR 876.5980 mfg.) K813526 Indications for Use | Diversion of fecal Diversion of fecal Colonic Ir… | 1984 |
| * | K813526 | Fecal Sanitary TubeSummary page 3…al Fecal Sanitary (Bowel Mgt Sys) (Bowel Mgt Sys) (HDC Corp.) Catheter (Bard) Tube (This Submission) | K012113 K841289 Exempt per (Leon's Fecal Tube 21CFR 876.5980 mfg.) K813526 Indications for Use | Diversion of fecal Diversion of fecal Colonic Irrigation Administration of Collection of fecal matter to mi… | 1982 |
| * | — | Virden Rectal Catheter Named without a submission number |
What descends from it? (16)
See all 164 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 20 years and passes through 2 companies; a new generation was cleared every 20.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K083153 (Hollister, Inc., 2009) has gone furthest, with 7 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?
Diversion of fecal mater 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 enemadmedication.
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/K023344 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023344: Indwelling Fecal Management System-Non-Sterile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023344
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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