# K040658: Bardex I.C. Latex Foley Catheter

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Sep 29, 2004 after 201 days
- Product code: MJC (Catheter, Urological (Antimicrobial) And Accessories)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
17 later devices descend from it; 3 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Bardex® I.C. Latex Foley Catheter: named in the summary without a submission number

## Most influential descendants
- K082815: Well Lead Silicone and Latex Foley Catheters (2008), 10 descendants of its own
- K091699: Amsure Hydrophilic Latex Foley Catheter (2009), 4 descendants of its own
- K162989: Rusch Simplastic Foley Catheters (2017), 2 descendants of its own
- K233094: Wellead® Latex Foley Catheter (2024), 1 descendant of its own
- K212077: Teleflex Rusch SoftSimplastic Foley Catheters (2023), 1 descendant 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.
- Jul 17, 2025 · Class II · Z-2590-2025: Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antim
- Jul 17, 2025 · Class II · Z-2591-2025: Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antim
- Jul 17, 2025 · Class II · Z-2589-2025: Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antim
- May 9, 2024 · Class II · Z-2154-2024: Some of the devices may function incorrectly resulting in no temperature display or erratic temperatures being displayed on the temperature monitoring devices.
- Aug 5, 2021 · Class II · Z-2525-2021: There is potential for packaging defects that may impact the sterile barrier.
- Aug 5, 2021 · Class II · Z-2527-2021: There is potential for packaging defects that may impact the sterile barrier.
- Aug 5, 2021 · Class II · Z-2523-2021: There is potential for packaging defects that may impact the sterile barrier.
- Apr 15, 2020 · Class II · Z-1970-2020: There is potential for a white paper-type residue attached to the catheter.

## Indications for use
The Bardex® I.C. latex Foley catheter is indicated for use in the drainage and/or collection and/or measurement of urine. Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as nephrostomy tract.

Source page: https://510kreport.com/device/K040658
Methodology: https://510kreport.com/methodology