# K110653: Cure Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cure Medical, LLC
- Decided: Aug 1, 2011 after 147 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: 3 generations back to K896729 (1990). 7 ancestors in all.
4 later devices descend from it; 2 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 1.
- K080881: Cure Catheter Closed System, Cure Medical, LLC (2008) Summary page 1.

## Most influential descendants
- 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
- Nov 11, 2014 · Class II · Z-0496-2015: Some of the intermediate boxes within lot 140417-3, were labeled as P8, a French Size 8 pediatric catheter but actually contain P10, French Size 10 pediatric catheters. Trying to use a P10 catheter fo

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

Source page: https://510kreport.com/device/K110653
Methodology: https://510kreport.com/methodology