# K060268: Pediatric Urinary Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Clay Kennard
- Decided: Feb 24, 2006 after 23 days
- Product code: GBM (Catheter, Urethral)
- 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 K031409 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031409: Urinary Catheters, Promedic, Inc. (2003) Summary page 1.

## Indications for use
The urinary catheter is for use with patients requiring urine drainage, with chronic urine retention and with post-void residual volume (PVR). The catheter is inserted into the urethra to reach the bladder allowing urine to drain.

Source page: https://510kreport.com/device/K060268
Methodology: https://510kreport.com/methodology