510(k) · Cleared
ClearedInstaflo Bowel Catheter System Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hollister, Inc. · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Apr 17, 2013 as substantially equivalent to K100273 (Hollister, Inc., 2010) after a 128-day review. Its family tree reaches back 5 generations to 1982. 1 later device descends from it.
- Decided
- Apr 17, 2013
- Review
- 128 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K813526 (1982). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK813526 Fecal Sanitary TubeLeon'S Fecal Sanitary Tub Mfg. · 1982
- 4 generations backK012113 Indwelling Fecal Management SystemBowel Management Systems, LLC · 2002
- 3 generations backK023344 Indwelling Fecal Management System-Non-SterileBowel Management Systems, LLC · 2002
- 2 generations backK083153 Actiflo Indwelling Bowel Catheter System Kit, Models: 32004, 32005…Hollister, Inc. · 2009
- 1 generation backK100273 Instaflo Bowel Catheter System KitHollister, Inc. · 2010
- This deviceK123804 Instaflo Bowel Catheter System KitHollister, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK133251 Bard Dignishield Stool Management SystemC.R. Bard, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- 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 |
|---|---|---|---|---|---|
| −5 | K813526 | Fecal Sanitary Tube | Leon'S Fecal Sanitary Tub Mfg. | 1982 | — |
| −4 | K012113 | Indwelling Fecal Management System | Bowel Management Systems, LLC | 2002 | — |
| −3 | K023344 | Indwelling Fecal Management System-Non-Sterile | Bowel Management Systems, LLC | 2002 | — |
| −2 | K083153 | Actiflo Indwelling Bowel Catheter System Kit, Models: 32004, 32005, 32006, 32007 | Hollister, Inc. | 2009 | — |
| −1 | K100273 | Instaflo Bowel Catheter System Kit | Hollister, Inc. | 2010 | — |
| 0 (this device) | K123804 | Instaflo Bowel Catheter System Kit | Hollister, Inc. | 2013 | — |
| +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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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? (1)
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 |
|---|---|---|---|
| * | K100273 | Instaflo Bowel Catheter System KitSummary page 1…predicate device: I Product 310(k) IjistaFlo-Bowel Catheter System, IK100273 Kit Device Describ~tionm The hint&Flo Bowel Catheter System Kit contains twomain part… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133251 | Bard Dignishield Stool Management System | 2014 | 0 |
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 31 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K133251 (C.R. Bard, Inc., 2014) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
A bowel catheter system kit with odor barrier properties for diversion of liquid or semi-liquid stool to facilitate the collection of fecal matter in patients with little or no bowel control.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123804 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123804: Instaflo Bowel Catheter System Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123804
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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