# K260502: Liv Pre-lubricated Intermittent Catheter

- Pathway: 510(k) (Traditional)
- Applicant: HR Healthcare
- Decided: Mar 12, 2026 after 27 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 K010420 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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), Convatec (2025) Summary page 5.

## Indications for use
The Liv Pre-lubricated Intermittent Catheter is a device that is inserted through the urethra by female patients to drain urine from the bladder.

Source page: https://510kreport.com/device/K260502
Methodology: https://510kreport.com/methodology