# K003289: Bardex Latex-Free Temperature-Sensing Foley Catheter (Uncoated); Bardex Lubri-Sil Temperature-Sensing Foley Catheter (LU

- Pathway: 510(k) (Abbreviated)
- Applicant: C.R. Bard, Inc.
- Decided: Jan 5, 2001 after 77 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
No predicates in its family tree.
6 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K070582: Bardex All-Silicone, Bardex Lubri-Sil, and Bardex Lubri-Sil I.C. Temperature-Sensing Foley Catheters (2007), 5 descendants of its own
- 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

Source page: https://510kreport.com/device/K003289
Methodology: https://510kreport.com/methodology