# K070582: Bardex All-Silicone, Bardex Lubri-Sil, and Bardex Lubri-Sil I.C. Temperature-Sensing Foley Catheters

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Dec 7, 2007 after 281 days
- Product code: EZL (Catheter, Retention Type, Balloon)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003289 (2001). 1 ancestor in all.
5 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003289: Bardex Latex-Free Temperature-Sensing Foley Catheter (Uncoated); Bardex Lubri-Sil Temperature-Sensing Foley Catheter (LU, C.R. Bard, Inc. (2001) Summary page 2.

## Most influential descendants
- K153655: Accuryn Monitoring System (2016), 4 descendants of its own
- K210570: TraumaGuard Intra-abdominal Pressure Sensing System (2021), 2 descendants of its own
- K240057: TraumaGuard Intra-abdominal Pressure Sensing System (2024), 1 descendant of its own
- K260756: TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221) (2026), 0 descendants of its own
- K221020: Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F (2023), 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.
- Jun 18, 2025 · Class II · Z-2462-2025: Foley catheter may have an obstructed lumen, which may result in an inability to drain the bladder, of urine and may include pelvic or abdominal pain, flank pain, bladder dysfunction, obstructive urop
- Aug 5, 2021 · Class II · Z-2538-2021: There is potential for packaging defects that may impact the sterile barrier.
- Aug 5, 2021 · Class II · Z-2521-2021: There is potential for packaging defects that may impact the sterile barrier.

## Indications for use
The Bardex-8 Temperature-Sensing Foley Catheter, when connected to a Bard CritiCore e -or Urotrack 224 monitor, or other 400-series Temperature Monitors, is intended for use in the drainage and/or collection and/or measurement of urine and in conjunction with an electronic urine monitor for the monitoring of core body temperature, in degrees Fahrenheit and degrees Celsius.

Source page: https://510kreport.com/device/K070582
Methodology: https://510kreport.com/methodology