510(k) · Cleared

Cleared

Rectal Irrigation Tube

K841289510(k) TraditionalCleared Jul 6, 1984100-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

Hdc Corp. · KNT Tubes, Gastrointestinal (And Accessories)

Cleared on Jul 6, 1984 after a 100-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 27 later devices descend from it.

Decided: Jul 6, 1984
Review: 100 days
Class: Class II
Product code: KNT
Recalls: None
Predicates: 0

27 later devices descend from it, 2 citing it directly.

This deviceK841289 Rectal Irrigation TubeHdc Corp. · 1984
Descendant · cites it directly · 26 of its ownK012113 Indwelling Fecal Management SystemBowel Management Systems, LLC · 2002
Descendant · cites it directly · 16 of its ownK023344 Indwelling Fecal Management System-Non-SterileBowel Management Systems, LLC · 2002
Descendant · 2 generations on · 14 of its ownK032734 Convatec Fecal Management SystemConvatec, A Bristol-Myers Squibb Co. · 2004 · Recalled
Descendant · 2 generations on · 8 of its ownK112342 Flexi-Seal Signal Fecal Management SystemConvatec, Inc. · 2012
Descendant · 2 generations on · 7 of its ownK083153 Actiflo Indwelling Bowel Catheter System Kit, Models: 32004, 32005…Hollister, Inc. · 2009

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

2002high 3 (2014) · low 0 (2003)2026

Most influential descendants

Showing 5 of 27 · See all

K012113Indwelling Fecal Management SystemBowel Management Systems, LLC · 2002 · cites it directly26descendants
K023344Indwelling Fecal Management System-Non-SterileBowel Management Systems, LLC · 2002 · cites it directly16descendants
K032734Convatec Fecal Management SystemConvatec, A Bristol-Myers Squibb Co. · 2004 · 2 generations on14descendants
K112342Flexi-Seal Signal Fecal Management SystemConvatec, Inc. · 2012 · 2 generations on8descendants
K083153Actiflo Indwelling Bowel Catheter System Kit, Models: 32004, 32005, 32006, 32007Hollister, Inc. · 2009 · 2 generations on7descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K841289	Rectal Irrigation Tube	Hdc Corp.	1984	—
+1	K012113	Indwelling Fecal Management System	Bowel Management Systems, LLC	2002	—
+1	K023344	Indwelling Fecal Management System-Non-Sterile	Bowel Management Systems, LLC	2002	—
+2	K032734	Convatec Fecal Management System	Convatec, A Bristol-Myers Squibb Co.	2004	3
+2	K112342	Flexi-Seal Signal Fecal Management System	Convatec, Inc.	2012	—
+2	K083153	Actiflo Indwelling Bowel Catheter System Kit, Models: 32004, 32005, 32006, 32007	Hollister, Inc.	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	2	0
2004	1	0
2008	1	0
2009	2	0
2010	2	0
2011	1	0
2012	2	0
2013	1	0
2014	3	0
2015	2	0
2016	1	0
2017	2	0
2019	2	0
2020	1	0
2021	1	0
2023	1	0
2025	2	0

FIG. 1 — Lineage of K841289, 1984–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (27)

See all 27

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

Number	Device	Applicant	Decided	Descendants
K012113	Indwelling Fecal Management System	Bowel Management Systems, LLC	2002	26
K023344	Indwelling Fecal Management System-Non-Sterile	Bowel Management Systems, LLC	2002	16

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?

Of its descendants, K012113 (Bowel Management Systems, LLC, 2002) has gone furthest, with 26 descendants of its own.

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.

FDA decisions per year · KNT

4in 2025

2007high 16 (2014) · low 4 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KNT

136in 2025

2007high 259 (2014) · low 99 (2016)2026

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

Recalls per year · KNT

13in 2025

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

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

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	—

https://510kreport.com/device/K841289 · printed Nov 5, 2026

Cite this page

510(k) Report. “K841289: Rectal Irrigation Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K841289

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026