# K984136: Bardex Lubri-Sil I.C. Foley Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Bard Medical Div.
- Decided: Feb 16, 1999 after 90 days
- Product code: MJC (Catheter, Urological (Antimicrobial) And Accessories)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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® I.C. Foley Catheter (LATEx): named in the summary without a submission number

## Recalls of this device
- Jun 25, 2026 · Class II · Z-3116-2026: Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
- Aug 29, 2002 · Not classified · Z-1144-03: On some units the inflation valve labeling is reversed on the Prostate and Bladder balloon inflation ports.

## Indications for use
The Bardex® Lubri-Sil™ I.C. 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/K984136
Methodology: https://510kreport.com/methodology