# K910197: Hydrogel-Coated Urethral Catheters and Drains

- 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have 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
- K070879: Bard Malecot and Pezzer Drains (2007), 2 descendants of its own
- K101900: Hakki Urinary Catheter; Size 14, 16, 18, 20, 22, 24, 26 French (2011), 1 descendant of its own
- K191512: LotusCatheter (Lotus No Balloon Catheter) (2020), 0 descendants of its own

## Recalls of this device
- Jun 25, 2026 · Class II · Z-3114-2026: Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.

Source page: https://510kreport.com/device/K910197
Methodology: https://510kreport.com/methodology