# K910318: Bard (R) Hydrogel/Silver-Coated Foley Catheter

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Aug 18, 1994 after 1,302 days
- Product code: MJC (Catheter, Urological (Antimicrobial) And Accessories)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K983101: Bardex I.C 4-Way Foley Catheter Model 1865SIXX XX = 18,20,22,24 (1998), 0 descendants of its own
- K971627: Silicone Antibacterial Foley Catheter (1998), 0 descendants of its own

## Recalls of this device
- Jun 25, 2026 · Class II · Z-3116-2026: Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
- Aug 5, 2021 · Class II · Z-2524-2021: There is potential for packaging defects that may impact the sterile barrier.
- Aug 5, 2021 · Class II · Z-2526-2021: There is potential for packaging defects that may impact the sterile barrier.
- Aug 5, 2021 · Class II · Z-2522-2021: There is potential for packaging defects that may impact the sterile barrier.
- Dec 13, 2018 · Class II · Z-0803-2019: potential for urine leakage around the vent on the vented sample port
- Dec 6, 2018 · Class II · Z-0800-2019: Some SureStep" Foley Tray Systems with product catalog number A319418AM and lot number NGCT1929 contain vented sample ports that may have an increased likelihood of leaking urine from the vent on the 
- Dec 18, 2015 · Class II · Z-1359-2016: Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.
- Dec 18, 2015 · Class II · Z-1358-2016: Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.

Source page: https://510kreport.com/device/K910318
Methodology: https://510kreport.com/methodology