510(k) · Cleared

Cleared

Intermittent Urethral Catheters

K033023510(k) TraditionalCleared Dec 23, 200388-day reviewClass II21 CFR 876.5130

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

Rusch Intl. · KOD Catheter, Urological

Cleared on Dec 23, 2003 as substantially equivalent to K003784 (Mentor Corp., 2001) and 2 other predicates after an 88-day review. Its family tree reaches back 1 generation to 1990. 9 later devices descend from it.

Decided: Dec 23, 2003
Review: 88 days
Class: Class II
Product code: KOD
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K896729 (1990). 3 ancestors in all. 9 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK896729 Nelaton-, Female - or Tiemann CatheterUnoplast A/S · 1990 · Recalled
This deviceK033023 Intermittent Urethral CathetersRusch Intl. · 2003
Descendant · cites it directly · 5 of its ownK072539 Cure CatheterCure Medical, LLC · 2007 · Recalled
Descendant · 2 generations on · 4 of its ownK110653 Cure CatheterCure Medical, LLC · 2011 · Recalled
Descendant · 2 generations on · 3 of its ownK132500 Cure Catheter Female, Cure Catheter Male, Cure Catheter Coude, Cure…Cure Medical, LLC · 2013
Descendant · cites it directly · 2 of its ownK111405 Bever Unocated / Coated, Paediatric / Male / Female Nelaton-Tip /…Hangzhou Bever Medical Devices Co., Ltd. · 2012
Descendant · 3 generations on · 0 of its ownK260737 Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female…Convatec · 2026

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2007high 2 (2016) · low 0 (2008)2026

Most influential descendants

Showing 5 of 9 · See all

K072539Cure CatheterCure Medical, LLC · 2007 · cites it directly5descendants
K110653Cure CatheterCure Medical, LLC · 2011 · 2 generations on4descendants
K132500Cure Catheter Female, Cure Catheter Male, Cure Catheter Coude, Cure Catheter Pediatric…Cure Medical, LLC · 2013 · 2 generations on3descendants
K111405Bever Unocated / Coated, Paediatric / Male / Female Nelaton-Tip / Tiemann-Tip…Hangzhou Bever Medical Devices Co., Ltd. · 2012 · cites it directly2descendants
K260737Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure…Convatec · 2026 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K896729	Nelaton-, Female - or Tiemann Catheter	Unoplast A/S	1990	14
0 (this device)	K033023	Intermittent Urethral Catheters	Rusch Intl.	2003	—
+1	K072539	Cure Catheter	Cure Medical, LLC	2007	1
+2	K110653	Cure Catheter	Cure Medical, LLC	2011	1
+2	K132500	Cure Catheter Female, Cure Catheter Male, Cure Catheter Coude, Cure Catheter…	Cure Medical, LLC	2013	—
+1	K111405	Bever Unocated / Coated, Paediatric / Male / Female Nelaton-Tip / Tiemann-Tip…	Hangzhou Bever Medical Devices Co., Ltd.	2012	—
+3	K260737	Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 -…	Convatec	2026	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2011	1	0
2012	1	0
2013	1	0
2015	1	0
2016	2	0
2018	1	0
2026	1	0

FIG. 1 — Lineage of K033023, 1990–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 KOD? 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 KOD device

#1 K251864 Rubber Utility Catheterscore 10.9 · 1 generation · 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? (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.

Type	Number	Device	Applicant	Decided	Recalls
*	K003784	Mentor Self-Cath Plus Summary page 1 …ers are substantially equivalent in design and materials to: Mentor Self-Cath - Preamendment Mentor Self-Cath Plus - K003784 Maersk Female, Nelaton and Tiemann Catheters - Originally marketed by Unoplast A/S - K896729 R~s…	Mentor Corp.	2001	—
*	K896729	Nelaton-, Female - or Tiemann Catheter Summary page 1 …Cath - Preamendment Mentor Self-Cath Plus - K003784 Maersk Female, Nelaton and Tiemann Catheters - Originally marketed by Unoplast A/S - K896729 R~sch International SympaCath Hydrogel Coated Foley Catheter - K964575 =…	Unoplast A/S	1990	14
*	K964575	Sympacath Hydrogel Coated Foley Summary page 1 …ally marketed by Unoplast A/S - K896729 R~sch International SympaCath Hydrogel Coated Foley Catheter - K964575 Page 2 4. Description of the Device: in tw…	Rusch Intl.	1997	—
*	—	Mentor Self-Cath Named without a submission number			—

Also cleared against K003784: 2 other devices →

What descends from it? (9)

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

Number	Device	Applicant	Decided	Descendants
K072539	Cure Catheter	Cure Medical, LLC	2007	5
K111405	Bever Unocated / Coated, Paediatric / Male / Female Nelaton-Tip / Tiemann-Tip…	Hangzhou Bever Medical Devices Co., Ltd.	2012	2

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?

1 of the 3 ancestors has a recall of any class.
Of its descendants, K072539 (Cure Medical, LLC, 2007) has gone furthest, with 5 descendants of its own.
2 other devices also cite its predicate K003784.

How does its category compare?

All KOD devices

KOD Catheter, Urological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KOD

2in 2022

2007high 6 (2018) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KOD

251in 2018

2007high 251 (2018)2026

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

Recalls per year · KOD

1in 2023

2007high 47 (2011) · low 0 (2007)2026

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

Adverse event reports per year · KOD

1,389in 2025

2007high 1,873 (2017) · low 102 (2008)2025

MAUDE reports naming product code KOD, 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	0	—	0	180
2008	2	—	0	102
2009	1	—	15	183
2010	1	—	1	228
2011	2	—	47	209
2012	0	—	2	165
2013	0	—	0	393
2014	1	—	0	226
2015	0	—	0	418
2016	2	—	1	284
2017	1	—	0	1,873
2018	6	251	0	1,179
2019	1	—	1	1,167
2020	0	—	0	1,370
2021	1	—	0	1,388
2022	2	—	3	1,280
2023	0	—	1 (1)	1,160
2024	0	—	0	1,259
2025	0	—	0	1,389
2026	1	—	1	—

What is it indicated for?

The Intermittent Urethral Catheters are sterile, single-use, flexible tubular devices that are to be inserted through the urethra and used to pass fluids to or from urinary tracts.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033023 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033023: Intermittent Urethral Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033023

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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