# K251864: Rubber Utility Catheter

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Feb 23, 2026 after 251 days
- Product code: KOD (Catheter, Urological)
- 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 K041243 (2004). 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)
- K041243: Dover Red Rubber Robinson Catheter, Tyco Healthcare (2004) Summary page 5.

## Indications for use
The BD Rubber Utility Catheter is indicated for intermittent catheterization of the urethra to drain urine from the bladder by patients who are not capable of voluntary urination.

Source page: https://510kreport.com/device/K251864
Methodology: https://510kreport.com/methodology