# K251274: EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits

- Pathway: 510(k) (Traditional)
- Applicant: HR Healthcare
- Decided: Jan 29, 2026 after 280 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: 2 generations back to K000070 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183461: Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter, Teleflexmedical, Inc. (2019) Summary page 6.

## Indications for use
The EZ-Protect™ Hydrophilic Closed System Intermittent Catheter is intended to drain urine from the bladder.

Source page: https://510kreport.com/device/K251274
Methodology: https://510kreport.com/methodology