# K132500: Cure Catheter Female, Cure Catheter Male, Cure Catheter Coude, Cure Catheter Pediatric, Cure Catheter Hydrophilic Coated

- Pathway: 510(k) (Special)
- Applicant: Cure Medical, LLC
- Decided: Dec 23, 2013 after 136 days
- Product code: EZD (Catheter, Straight)
- 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: 4 generations back to K896729 (1990). 8 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072539: Cure Catheter, Cure Medical, LLC (2007) Summary page 2.
- K110653: Cure Catheter, Cure Medical, LLC (2011) Summary page 1.

## Most influential descendants
- 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

## Indications for use
The Cure Catheter® Hydrophilic Coated Is an Intermittent urinary catheter that Is inserted through the urethra and indicated for the purpose of bladder drainage. The urinary catheter comes In a variety of sizes, packaged sterile for single-use.

Source page: https://510kreport.com/device/K132500
Methodology: https://510kreport.com/methodology