# K033023: Intermittent Urethral Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Rusch Intl.
- Decided: Dec 23, 2003 after 88 days
- Product code: KOD (Catheter, Urological)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K896729 (1990). 3 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003784: Mentor Self-Cath Plus, Mentor Corp. (2001) Summary page 1.
- K896729: Nelaton-, Female - or Tiemann Catheter, Unoplast A/S (1990) Summary page 1.
- K964575: Sympacath Hydrogel Coated Foley, Rusch Intl. (1997) Summary page 1.
- (no number) Mentor Self-Cath: named in the summary without a submission number

## Most influential descendants
- K072539: Cure Catheter (2007), 5 descendants of its own
- K110653: Cure Catheter (2011), 4 descendants of its own
- K132500: Cure Catheter Female, Cure Catheter Male, Cure Catheter Coude, Cure Catheter Pediatric, Cure Catheter Hydrophilic Coated (2013), 3 descendants of its own
- K111405: Bever Unocated / Coated, Paediatric / Male / Female Nelaton-Tip / Tiemann-Tip Intermittent Catheter, (2012), 2 descendants of its own
- K260737: Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18). (2026), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K033023
Methodology: https://510kreport.com/methodology