# K091767: 3 Way Silicone Foley Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cook Urological, Inc.
- Decided: Oct 9, 2009 after 114 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: 3 generations back to K896053 (1990). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951106: Silicone Foley Catheter, Cook Urological, Inc. (1995) Summary page 1.
- K002868: Bard All-Silicone 3-Way Foley Catheter; Bard Lubri-Sil 3-Way Foley Catheter; Bard Lubri-Sil I.C. 3-Way Foley Catheter, C.R. Bard, Inc. (2000) Summary page 1.
- K082815: Well Lead Silicone and Latex Foley Catheters, Well Lead Medical Instruments (2008) Summary page 1.
- K013276: All-Silicone Foley Balloon Catheter (Two Way; Three Way, Radiopaque), Sewoon Medical Co., Ltd. (2002) Summary page 1.
- K981612: All Silicone Foley Catheter, Two-Way Foley Catheter, Three-Way Foley Catheter, Two-Way Radiopaque Foley Catheter, Rochester Medical Corp. (1998) Summary page 1.
- K070558: Bardex Lubri-Sil and Bardex Lubri-Sil I.C. Anti-Infective All-Silicone Foley Catheters, C.R. Bard, Inc. (2007) Summary page 1.

## Most influential descendants
- K181616: PSM 3-Way Silicone Foley Catheter (2018), 0 descendants of its own

## Indications for use
Used to provide continuous bladder irrigation of fluids and drainage of urine from the urinary tract. Urinary tract access is generally accomplished by insertion of the catheter through the urethra and into the bladder, but may also be accomplished by suprapubic placement or by Nephrostomy.

Source page: https://510kreport.com/device/K091767
Methodology: https://510kreport.com/methodology