# K132619: Classic Intermittent Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Flexicare Medical, Ltd.
- Decided: Oct 11, 2013 after 51 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). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951260: Urinary Intermittent Catheters W/O Hydromer Hydrophilic Lubricant, Biosearch Medical Products, Inc. (1995) Summary page 1.
- K100878: Self Cath Catheter, Coloplast Manufacturing Us, LLC (2010) Summary page 1.

## Indications for use
Classic' intermifttent catheters are Intended for use in Male, Female and Peedlatric patients when regular assisted bladder drainage has been instructed by.a physician. Classlem Intermittent catheters are Indicated for use by indivduals whose ability to void the bladder fully by natural bodily functions Is Impaired.

Source page: https://510kreport.com/device/K132619
Methodology: https://510kreport.com/methodology