# K254076: BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: May 29, 2026 after 162 days
- Product code: FCM (Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit))
- 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 K910653 (1991). 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)
- K910653: Touchless II Intermittent Catheter, C.R. Bard, Inc. (1991) Summary page 5.

## Indications for use
The BD Touchless™ Plus Unisex Urethral Catheter Kit is indicated for intermittent catheterization of the urethra to drain urine from the bladder by adult patients who are not capable of voluntary urination.

Source page: https://510kreport.com/device/K254076
Methodology: https://510kreport.com/methodology