510(k) Report

510(k) · Decided

Decided

Bard Dignishield Stool Management System

K133251510(k) TraditionalDecided May 9, 2014199-day reviewClass II21 CFR 876.5980

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

C.R. Bard, Inc. · KNT Tubes, Gastrointestinal (And Accessories)

Cleared on May 9, 2014 as substantially equivalent to K102391 (C.R. Bard, Inc., 2010) and 3 other predicates after a 199-day review. Its family tree reaches back 6 generations to 1982.

Decided
May 9, 2014
Review
199 days
Class
Class II
Product code
KNT
Recalls
None
Predicates
4

Its longest line of descent runs back 6 generations to K813526 (1982). 11 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2012: 1 other ancestor2010: 1 other ancestor2008: 1 other ancestor2004: 1 other ancestor1984: 1 other ancestorK813526 · Fecal Sanitary Tube · Leon'S Fecal Sanitary Tub Mfg. · 1982K012113 · Indwelling Fecal Management System · Bowel Management Systems, LLC · 2002K023344 · Indwelling Fecal Management System-Non-Sterile · Bowel Management Systems, LLC · 2002K083153 · Actiflo Indwelling Bowel Catheter System Kit, Models: 32004, 32005, 32006, 32007 · Hollister, Inc. · 2009K100273 · Instaflo Bowel Catheter System Kit · Hollister, Inc. · 2010K123804 · Instaflo Bowel Catheter System Kit · Hollister, Inc. · 201319801985199019952000200520102015
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 1 other ancestor3 generations back: 1 other ancestor K123804 · Instaflo Bowel Catheter System Kit · Hollister, Inc. · 2013K100273 · Instaflo Bowel Catheter System Kit · Hollister, Inc. · 2010K083153 · Actiflo Indwelling Bowel Catheter System Kit, Models: 32004, 32005, 32006, 32007 · Hollister, Inc. · 2009K023344 · Indwelling Fecal Management System-Non-Sterile · Bowel Management Systems, LLC · 2002K012113 · Indwelling Fecal Management System · Bowel Management Systems, LLC · 2002K813526 · Fecal Sanitary Tube · Leon'S Fecal Sanitary Tub Mfg. · 1982−50
  1. Root · 6 generations backK813526 Fecal Sanitary TubeLeon'S Fecal Sanitary Tub Mfg. · 1982
  2. 5 generations backK012113 Indwelling Fecal Management SystemBowel Management Systems, LLC · 2002
  3. 4 generations backK023344 Indwelling Fecal Management System-Non-SterileBowel Management Systems, LLC · 2002
  4. 3 generations backK083153 Actiflo Indwelling Bowel Catheter System Kit, Models: 32004, 32005…Hollister, Inc. · 2009
  5. 2 generations backK100273 Instaflo Bowel Catheter System KitHollister, Inc. · 2010
  6. 1 generation backK123804 Instaflo Bowel Catheter System KitHollister, Inc. · 2013
  7. This deviceK133251 Bard Dignishield Stool Management SystemC.R. Bard, Inc. · 2014
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K813526Fecal Sanitary TubeLeon'S Fecal Sanitary Tub Mfg.1982—
−5K012113Indwelling Fecal Management SystemBowel Management Systems, LLC2002—
−4K023344Indwelling Fecal Management System-Non-SterileBowel Management Systems, LLC2002—
−3K083153Actiflo Indwelling Bowel Catheter System Kit, Models: 32004, 32005, 32006, 32007Hollister, Inc.2009—
−2K100273Instaflo Bowel Catheter System KitHollister, Inc.2010—
−1K123804Instaflo Bowel Catheter System KitHollister, Inc.2013—
0 (this device)K133251Bard Dignishield Stool Management SystemC.R. Bard, Inc.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
200410
200810
201010
201210
FIG. 1 — Lineage of K133251, 1982–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K261890 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D®score 12.7 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K102391Bard Dignishield Stool Management System
Summary page 1
…Product Code: KNT Legally marketed devices to which substantial equivalence is claimed: * BardO DigniShieldO Stool Management System, K102391 * Bard® DigniCare Stool Management System, K073598 * ConvaTec Flexi-SealO SignalT m Fecal Management System, K112342…
C.R. Bard, Inc.2010—
*K073598Bard Dignicare Stool Management System
Summary page 1
…ally marketed devices to which substantial equivalence is claimed: * BardO DigniShieldO Stool Management System, K102391 * Bard® DigniCare Stool Management System, K073598 * ConvaTec Flexi-SealO SignalT m Fecal Management System, K112342 * Hollister InstaFlo Bowel Catheter System Kit, K12380…
C.R. Bard, Inc.2008—
*K112342Flexi-Seal Signal Fecal Management System
Summary page 1
…BardO DigniShieldO Stool Management System, K102391 * Bard® DigniCare Stool Management System, K073598 * ConvaTec Flexi-SealO SignalT m Fecal Management System, K112342 * Hollister InstaFlo Bowel Catheter System Kit, K123804 Device Description The Bard® DigniShieldO Stool Management System is…
Convatec, Inc.2012—
*K123804Instaflo Bowel Catheter System Kit
Summary page 1
…rd® DigniCare Stool Management System, K073598 * ConvaTec Flexi-SealO SignalT m Fecal Management System, K112342 * Hollister InstaFlo Bowel Catheter System Kit, K123804 Device Description The Bard® DigniShieldO Stool Management System is sold as a tray (kit) including a catheter, collection bag a…
Hollister, Inc.2013—

Also cleared against K102391: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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 32 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
  • 1 of the 11 ancestors has a recall of any class.
  • 1 other device also cites its predicate K102391.

How does its category compare?

All KNT devices

KNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · KNT

4in 2025

2007: 102008: 102009: 112010: 122011: 72012: 122013: 72014: 162015: 102016: 62017: 92018: 72019: 102020: 52021: 62022: 72023: 52024: 92025: 42026 (partial year): 3
2007high 16 (2014) · low 4 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KNT

136in 2025

2007: 118 days median2008: 115 days median2009: 102 days median2010: 104 days median2011: 211 days median2012: 107 days median2013: 128 days median2014: 259 days median2015: 140 days median2016: 99 days median2017: 247 days median2018: 149 days median2019: 126 days median2020: 102 days median2021: 121 days median2022: 110 days median2023: 162 days median2024: 103 days median2025: 136 days median2026 (partial year): 105 days median
2007high 259 (2014) · low 99 (2016)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KNT

13in 2025

2007: 12008: 822009: 92010: 32011: 22012: 12015: 12016: 32017: 42018: 22019: 22020: 12021: 22022: 1, 1 Class I2023: 22025: 132026 (partial year): 20
2007high 82 (2008) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · KNT

1,451in 2025

2007: 3002008: 8672009: 8182010: 5172011: 5312012: 5282013: 7472014: 1,0302015: 1,0482016: 1,2512017: 1,6722018: 1,9012019: 1,8382020: 1,6412021: 1,6552022: 1,6502023: 1,8632024: 1,3442025: 1,451
2007high 1,901 (2018) · low 300 (2007)2025

MAUDE reports naming product code KNT, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007101181300
20081011582867
2009111029818
2010121043517
201172112531
2012121071528
201371280747
20141625901,030
20151014011,048
201669931,251
2017924741,672
2018714921,901
20191012621,838
2020510211,641
2021612121,655
202271101 (1)1,650
2023516221,863
2024910301,344
20254136131,451
2026310520—

What is it indicated for?

The Bard® DigniShield® Stool Management System with odor barrier properties is intended for fecal management by diverting and collecting liquid or semi-liquid stool to minimize skin contact in bedridden patients and to provide access for the administration of medications.

Adult use only.

Indications for use as stated in the FDA summary.

Also cleared against K102391

1 other device cites the same predicate.

  • K133465Consure Stool Management SystemConsure Medical Pvt, Ltd. · 2014

More from C.R. Bard, Inc.

711 FDA decisions under this applicant name. See the company

  • P800002/S036Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web WebberC.R. Bard, Inc. · 2026
  • P800002/S035Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven WebC.R. Bard, Inc. · 2026
  • K253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric…C.R. Bard, Inc. · 2026
  • P170042/S015Covera™ Vascular Covered StentC.R. Bard, Inc. · 2026
  • K254076BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter KitC.R. Bard, Inc. · 2026

Recent decisions in KNT

The KNT category page

  • K262038danumed StomaMeterDanumed Medizintechnik GmbH · 2026
  • K26189052Fr ViSiGi LUX™; 52Fr ViSiGi 3D®Boehringer Laboratories, LLC · 2026
  • K253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric…C.R. Bard, Inc. · 2026
  • K250389XNY Disposable Gastric Calibration TubeChangzhou Xin Neng Yuan Medical Stapler Co.,Ltd · 2025
  • K243228Flexi-Seal AIR (with ENFit Connector)Convatec · 2025

https://510kreport.com/device/K133251 · printed Nov 6, 2026

Cite this page

510(k) Report. “K133251: Bard Dignishield Stool 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/K133251

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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