# K910195: Bard Hydrogel-Coated Foley Catheters

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Aug 9, 1991 after 205 days
- Product code: EZC (Catheter, Coude)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 2 cite it directly.
1 of 9 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K990500: Kendall Ultramer Coude Foley Catheter, Model 1416C, Kendall Curity Coude Foley Catheter Tray, Model 6946C (1999), 5 descendants of its own
- K042110: Beamcath (2005), 3 descendants of its own
- K150699: Bard LubriGuard Foley Catheter (2015), 1 descendant of its own
- K131655: Lighthouse (TM) Urinary Catheter (2013), 1 descendant of its own
- K180781: Bard Vertus Foley Catheter (2018), 0 descendants of its own

## Recalls of this device
- Dec 13, 2017 · Class II · Z-2064-2018: Foley Catheter with Incorrect Retainer Cap Print

Source page: https://510kreport.com/device/K910195
Methodology: https://510kreport.com/methodology