510(k) Report

510(k) · Decided

Decided

Actiflo Indwelling Bowel Catheter System Kit, Models: 32004, 32005, 32006, 32007

K083153510(k) TraditionalDecided Feb 4, 2009103-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

Hollister, Inc. · KNT Tubes, Gastrointestinal (And Accessories)

Cleared on Feb 4, 2009 as substantially equivalent to K023344 (Bowel Management Systems, LLC, 2002) and 1 other predicate after a 103-day review. Its family tree reaches back 3 generations to 1982. 7 later devices descend from it.

Decided
Feb 4, 2009
Review
103 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. 7 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1984: 1 other ancestor2010: 2 descendants cleared2013: 1 descendant cleared2014: 2 descendants cleared2016: 1 descendant cleared2021: 1 descendant clearedK813526 · 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 · 200219801990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant K023344 · 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. · 19820
  1. Root · 3 generations backK813526 Fecal Sanitary TubeLeon'S Fecal Sanitary Tub Mfg. · 1982
  2. 2 generations backK012113 Indwelling Fecal Management SystemBowel Management Systems, LLC · 2002
  3. 1 generation backK023344 Indwelling Fecal Management System-Non-SterileBowel Management Systems, LLC · 2002
  4. This deviceK083153 Actiflo Indwelling Bowel Catheter System Kit, Models: 32004, 32005…Hollister, Inc. · 2009
  5. Descendant · cites it directly · 4 of its ownK102391 Bard Dignishield Stool Management SystemC.R. Bard, Inc. · 2010
  6. Descendant · 2 generations on · 2 of its ownK133465 Consure Stool Management SystemConsure Medical Pvt, Ltd. · 2014
  7. Descendant · cites it directly · 2 of its ownK100273 Instaflo Bowel Catheter System KitHollister, Inc. · 2010
  8. Descendant · 3 generations on · 1 of its ownK153506 Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora…Consure Medical Pvt, Ltd. · 2016
  9. Descendant · 2 generations on · 1 of its ownK123804 Instaflo Bowel Catheter System KitHollister, Inc. · 2013

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2010: 22013: 12014: 22016: 12021: 1
2010high 2 (2010) · low 0 (2011)2026

Most influential descendants

Showing 5 of 7 · See all
  • K102391Bard Dignishield Stool Management SystemC.R. Bard, Inc. · 2010 · cites it directly4descendants
  • K133465Consure Stool Management SystemConsure Medical Pvt, Ltd. · 2014 · 2 generations on2descendants
  • K100273Instaflo Bowel Catheter System KitHollister, Inc. · 2010 · cites it directly2descendants
  • K153506Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool…Consure Medical Pvt, Ltd. · 2016 · 3 generations on1descendant
  • K123804Instaflo Bowel Catheter System KitHollister, Inc. · 2013 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K813526Fecal Sanitary TubeLeon'S Fecal Sanitary Tub Mfg.1982—
−2K012113Indwelling Fecal Management SystemBowel Management Systems, LLC2002—
−1K023344Indwelling Fecal Management System-Non-SterileBowel Management Systems, LLC2002—
0 (this device)K083153Actiflo Indwelling Bowel Catheter System Kit, Models: 32004, 32005, 32006, 32007Hollister, Inc.2009—
+1K102391Bard Dignishield Stool Management SystemC.R. Bard, Inc.2010—
+2K133465Consure Stool Management SystemConsure Medical Pvt, Ltd.2014—
+1K100273Instaflo Bowel Catheter System KitHollister, Inc.2010—
+3K153506Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida…Consure Medical Pvt, Ltd.2016—
+2K123804Instaflo Bowel Catheter System KitHollister, Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201020
201310
201420
201610
202110
FIG. 1 — Lineage of K083153, 1982–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K023344Indwelling Fecal Management System-Non-Sterile
Summary page 1
…Product 510(k) Indwelling Fecal Management K023344 System- Non-Sterile Indwelling Fecal Management…
Bowel Management Systems, LLC2002—
*K012113Indwelling Fecal Management System
Summary page 1
…cal Management K023344 System- Non-Sterile Indwelling Fecal Management K012113 System (IFMS) Device Description:The ActiFlo Indw…
Bowel Management Systems, LLC2002—

Also cleared against K023344: 3 other devices →

What descends from it? (7)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K102391Bard Dignishield Stool Management SystemC.R. Bard, Inc.20104
K100273Instaflo Bowel Catheter System KitHollister, Inc.20102

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 27 years and passes through 3 companies; a new generation was cleared every 6.2 years on median.
  • None of the 4 ancestors has a recall.
  • Of its descendants, K102391 (C.R. Bard, Inc., 2010) has gone furthest, with 4 descendants of its own.
  • 3 other devices also cite its predicate K023344.

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. 2009, 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 ActiFlo Indwelling Bowel Catheter System is intended for diversion of fecal matter to minimize external contact with the patient's skin, to facilitate the collection of fecal matter for patients requiring stool management, to provide access for colonic irrigation and to administer enema/medications.

Indications for use as stated in the FDA summary.

Also cleared against K023344

3 other devices cite the same predicate.

  • K133881Macy CatheterHospi Corporation · 2014
  • K083770Coloplast Peristeen Anal Irrigation (Pai) SystemColoplast A/S · 2009
  • K073598Bard Dignicare Stool Management SystemC.R. Bard, Inc. · 2008

More from Hollister, Inc.

85 FDA decisions under this applicant name. See the company

  • K123804Instaflo Bowel Catheter System KitHollister, Inc. · 2013
  • K100273Instaflo Bowel Catheter System KitHollister, Inc. · 2010
  • K090960Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144…Hollister, Inc. · 2009
  • K050483Evadri Bladder Control SystemsHollister, Inc. · 2005
  • K040779Restore Wound CleanserHollister, Inc. · 2004

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/K083153 · printed Nov 6, 2026

Cite this page

510(k) Report. “K083153: Actiflo Indwelling Bowel Catheter System Kit, Models: 32004, 32005, 32006, 32007.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083153

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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