# K981612: All Silicone Foley Catheter, Two-Way Foley Catheter, Three-Way Foley Catheter, Two-Way Radiopaque Foley Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Rochester Medical Corp.
- Decided: Jul 8, 1998 after 63 days
- Product code: EZL (Catheter, Retention Type, Balloon)
- 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
Longest line of descent: 1 generation back to K896053 (1990). 1 ancestor in all.
19 later devices descend from it; 4 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K896053: All Silicone Foley Catheter, Rochester Medical Corp. (1990) Summary page 1.
- (no number) Rusch Foley Catheters: named in the summary without a submission number
- (no number) Bard Urological Inc. Foley Catheters: 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
- 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
- K142635: Medline Silicone Foley Catheter (2015), 1 descendant of its own

## Indications for use
Urethral catheterization for bladder drainage. Urethral catheterization for bladder drainage and bladder irrigation. Urethral catheterization for bladder drainage with radiopaque substance for radiographic visualization. For urological use only.

Source page: https://510kreport.com/device/K981612
Methodology: https://510kreport.com/methodology