# K080881: Cure Catheter Closed System

- Pathway: 510(k) (Traditional)
- Applicant: Cure Medical, LLC
- Decided: Jun 11, 2008 after 72 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 K010420 (2001). 1 ancestor in all.
10 later devices descend from it; 4 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)
- K010420: Rusch MMG/O'neil Catheter, Rusch, Inc. (2001) 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
- K221593: Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus (2022), 2 descendants of its own
- K250699: Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist Female 14 Catheter (T14); Cure Twist Female 16 Catheter (T16); Cure Twist Female 8 Catheter Kit with supplies (T8K); Cure Twist Female 10 Catheter Kit with supplies (T10K); Cure Twist Female 12 Catheter Kit with supplies (T12K); Cure Twist Female 14 Catheter Kit with supplies (T14K); Cure Twist Female 16 Catheter Kit with supplies (T16K) (2025), 1 descendant of its own
- K230400: Cure Catheter Closed System; Cure Dextra Closed System (2023), 1 descendant of its own

## Indications for use
The Cure Catheter TM Closed System is an intermittent urinary catheter attached to a collection bag 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/K080881
Methodology: https://510kreport.com/methodology