# K896053: All Silicone Foley Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Rochester Medical Corp.
- Decided: Feb 12, 1990 after 117 days
- Product code: KOD (Catheter, Urological)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
21 later devices descend from it; 2 cite it directly.
0 of 22 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
- K981612: All Silicone Foley Catheter, Two-Way Foley Catheter, Three-Way Foley Catheter, Two-Way Radiopaque Foley Catheter (1998), 19 descendants of its own
- K082815: Well Lead Silicone and Latex Foley Catheters (2008), 10 descendants of its own
- K130908: Disposable Silicone Foley Catheter (2013), 6 descendants of its own
- K013276: All-Silicone Foley Balloon Catheter (Two Way; Three Way, Radiopaque) (2002), 2 descendants of its own
- K233094: Wellead® Latex Foley Catheter (2024), 1 descendant of its own

Source page: https://510kreport.com/device/K896053
Methodology: https://510kreport.com/methodology