# K103086: Dynarex Intermittent Catheters, Male, Female, Pediatric

- Pathway: 510(k) (Traditional)
- Applicant: Dynarex Corporation
- Decided: Jun 7, 2011 after 231 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 K003784 (2001). 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)
- K100878: Self Cath Catheter, Coloplast Manufacturing Us, LLC (2010) Summary page 1.

## Indications for use
The Dynarex Intermittent Catheter is intended for use in male, female, and pediatric patients (children, adolescents and transitional adolescents) requiring bladder drainage as determined by their physician. This device is indicated for those individuals unable to promote a natural urine flow or for those who have a significant volume of residual urine following a natural bladder-voiding episode. The catheter should not be retained in the human body for more than 24 hours.

Source page: https://510kreport.com/device/K103086
Methodology: https://510kreport.com/methodology