# K760093: Catheter, Silicone Foley (Bardex)

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Aug 23, 1976 after 63 days
- Product code: GBM (Catheter, Urethral)
- 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.
6 later devices descend from it; 4 cite it directly.
0 of 7 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
- K961697: Opticon Female Urinary Incontinence Catheter for Continuous Drainage (1996), 5 descendants of its own
- K023090: Option-VF Urinary Catheter, FV14218 (2003), 3 descendants of its own
- K033830: Option-VF Urinary Catheter with Adaptor, Model FVA14218; Option-V Continuous Drainage Adaptor, Model CDA1000 (2004), 2 descendants of its own
- K041983: Option-VM Urinary Catheter/Adpater, Models MV39016, MVA39016 (2004), 1 descendant of its own
- K062240: Carevent (2006), 0 descendants of its own

## Recalls of this device
- Aug 5, 2021 · Class II · Z-2533-2021: There is potential for packaging defects that may impact the sterile barrier.

Source page: https://510kreport.com/device/K760093
Methodology: https://510kreport.com/methodology