# K984084: Bardex Lubri-Sil Foley Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Bard Medical Div.
- Decided: Feb 1, 1999 after 77 days
- Product code: EZL (Catheter, Retention Type, Balloon)
- 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.
11 later devices descend from it; 4 cite it directly.
0 of 12 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® All-Silicone Foley Catheter: named in the summary without a submission number
- (no number) Bardex® Lubricath® Foley Catheter: named in the summary without a submission number

## Most influential descendants
- K070508: Bardex Lubri-Sil All-Silicone Lubricious Coated Foley Catheter 6 FR (2007), 6 descendants of its own
- K091699: Amsure Hydrophilic Latex Foley Catheter (2009), 4 descendants of its own
- K192034: HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc (2020), 3 descendants of its own
- K221625: 2-Way 100% Silicone ClearTract Catheter (2022), 2 descendants of its own
- K162989: Rusch Simplastic Foley Catheters (2017), 2 descendants of its own

## Recalls of this device
- Jun 25, 2026 · Class II · Z-3115-2026: Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.

## Indications for use
The Bardex® Lubri-Sil™ 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 a nephrostomy tract. Some Foley catheters, especially those with larger (30cc) balloons are used to assist in hemostasis following surgery such as transurethral resection of the prostate.

Source page: https://510kreport.com/device/K984084
Methodology: https://510kreport.com/methodology