510(k) · Decided
DecidedBard Dignishield Stool Management System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Dec 22, 2010 as substantially equivalent to K073598 (C.R. Bard, Inc., 2008) and 1 other predicate after a 121-day review. Its family tree reaches back 4 generations to 1982. 4 later devices descend from it.
- Decided
- Dec 22, 2010
- Review
- 121 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K813526 (1982). 7 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK813526 Fecal Sanitary TubeLeon'S Fecal Sanitary Tub Mfg. · 1982
- 3 generations backK012113 Indwelling Fecal Management SystemBowel Management Systems, LLC · 2002
- 2 generations backK023344 Indwelling Fecal Management System-Non-SterileBowel Management Systems, LLC · 2002
- 1 generation backK073598 Bard Dignicare Stool Management SystemC.R. Bard, Inc. · 2008
- This deviceK102391 Bard Dignishield Stool Management SystemC.R. Bard, Inc. · 2010
- Descendant · cites it directly · 2 of its ownK133465 Consure Stool Management SystemConsure Medical Pvt, Ltd. · 2014
- Descendant · 2 generations on · 1 of its ownK153506 Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora…Consure Medical Pvt, Ltd. · 2016
- Descendant · 3 generations on · 0 of its ownK212444 Qora Stool Management KitCm Technologies, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK133251 Bard Dignishield Stool Management SystemC.R. Bard, Inc. · 2014
Most influential descendants
Showing 4 of 4 · See all- K133465Consure Stool Management SystemConsure Medical Pvt, Ltd. · 2014 · cites it directly2descendants
- K153506Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool…Consure Medical Pvt, Ltd. · 2016 · 2 generations on1descendant
- K212444Qora Stool Management KitCm Technologies, Inc. · 2021 · 3 generations on0descendants
- K133251Bard Dignishield Stool Management SystemC.R. Bard, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K813526 | Fecal Sanitary Tube | Leon'S Fecal Sanitary Tub Mfg. | 1982 | — |
| −3 | K012113 | Indwelling Fecal Management System | Bowel Management Systems, LLC | 2002 | — |
| −2 | K023344 | Indwelling Fecal Management System-Non-Sterile | Bowel Management Systems, LLC | 2002 | — |
| −1 | K073598 | Bard Dignicare Stool Management System | C.R. Bard, Inc. | 2008 | — |
| 0 (this device) | K102391 | Bard Dignishield Stool Management System | C.R. Bard, Inc. | 2010 | — |
| +1 | K133465 | Consure Stool Management System | Consure Medical Pvt, Ltd. | 2014 | — |
| +2 | K153506 | Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida… | Consure Medical Pvt, Ltd. | 2016 | — |
| +3 | K212444 | Qora Stool Management Kit | Cm Technologies, Inc. | 2021 | — |
| +1 | K133251 | Bard Dignishield Stool Management System | C.R. Bard, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2016 | 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? (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 |
|---|---|---|---|
| * | K073598 | Bard Dignicare Stool Management SystemSummary page 1…ulation: 21 CFR § 876.5980 Regulatory Class: 11 Product Code: 78 KNT - Gastrointestinal tube and accessories Predicate Device(s): BARD® DigniCare™ Stool C. R. Bard, [nc. K073598 Management System ActiFlo™ Indwelling Catheter Hollister Inc. K083153 System Kit Device Description: The BARD® DigniShield™ Stoo… | 2008 |
| * | K083153 | Actiflo Indwelling Bowel Catheter System Kit, Models: 32004, 32005, 32006, 32007Summary page 1…Gastrointestinal tube and accessories Predicate Device(s): BARD® DigniCare™ Stool C. R. Bard, [nc. K073598 Management System ActiFlo™ Indwelling Catheter Hollister Inc. K083153 System Kit Device Description: The BARD® DigniShield™ Stool Management System is sold as a tray (kit). The catheter portion of… | 2009 |
What descends from it? (4)
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 28 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K133465 (Consure Medical Pvt, Ltd., 2014) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K073598.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
The BARD® DigniShield™ Stool Management System is intended for
fecal management by diverting and collecting liquid or semi-liquid stool to minimize skin
contact in bedridden patients.
Adult Use Only
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/K102391 · printed Nov 5, 2026
Cite this page
510(k) Report. “K102391: Bard Dignishield Stool Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K102391
Report an extraction error
Are you the manufacturer?
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