# K072539: Cure Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cure Medical, LLC
- Decided: Sep 13, 2007 after 3 days
- Product code: EZD (Catheter, Straight)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K896729 (1990). 4 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033023: Intermittent Urethral Catheters, Rusch Intl. (2003) Summary page 1.

## Most influential descendants
- 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
- 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
- K181445: AMSure Hydrophilic Intermittent Catheter (2018), 0 descendants of its own
- K151745: FULL CARE Disposable PVC Nelaton Catheter (2016), 0 descendants of its own

## Recalls of this device
- Sep 19, 2012 · Class II · Z-0004-2013: The firm initiated the product recall because labeling on some of the intermediate boxes of catheters identify the contents to be M16C, a coud-tip catheters while the actual contents are M16Fr male, 1

## Indications for use
The Cure Catheter is an intermittent urinary catheter that is inserted through the urethra and indicated for the purpose of bladder drainage for males and females. The urinary catheter comes in a variety of sizes packaged sterile for single-use.

Source page: https://510kreport.com/device/K072539
Methodology: https://510kreport.com/methodology