# K070508: Bardex Lubri-Sil All-Silicone Lubricious Coated Foley Catheter 6 FR

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Mar 9, 2007 after 15 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
Longest line of descent: 1 generation back to K984084 (1999). 3 ancestors in all.
6 later devices descend from it; 2 cite 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)
- K000723: Hydrophilic Silicone Foley Catheter and Personal Catheter (Hydrophilic and Non-Hydrophilic), Rochester Medical Corp. (2000) Summary page 3.
- K984084: Bardex Lubri-Sil Foley Catheter, Bard Medical Div. (1999) Summary page 3.
- 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 3.

## Most influential descendants
- K091699: Amsure Hydrophilic Latex Foley Catheter (2009), 4 descendants of its own
- K162989: Rusch Simplastic Foley Catheters (2017), 2 descendants of its own
- K212077: Teleflex Rusch SoftSimplastic Foley Catheters (2023), 1 descendant of its own
- K252537: Rusch SoftSimplastic Foley Catheters (2026), 0 descendants of its own
- K140667: Well Lead Hydrophilic Silicone Foley Catheter (2014), 0 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® All-Silicone Lubricious Coated Foley Catheter 6 Fr 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 nephrostomy tract.

Source page: https://510kreport.com/device/K070508
Methodology: https://510kreport.com/methodology