# K042709: Dover Silver Temperature Sensing Foley Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Tyco Healthcare
- Decided: Jan 18, 2005 after 110 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
Longest line of descent: 1 generation back to K933400 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933400: Kendall Curity 100% Silicone Foley Catheter W/Temperature Sensor, Kendall Healthcare Products Co. Div.Of Tyco Health (1993) Summary page 1.
- K024010: Dover Silver Hydrogel Coated Silicone Foley Catheter, The Kendall Company Div. of Tyco Healthcare Group (2003) Summary page 1.

## Indications for use
The proposed catheters are intended for use in the drainage/collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgical or post-surgical intervals. General drainage is accomplished by inserting the catheter through the urethra and into the urine bladder. The catheter is retained in the bladder by inflation of balloon. Drainage is sometimes accomplished by suprapubic or other placement of the catheter.

Source page: https://510kreport.com/device/K042709
Methodology: https://510kreport.com/methodology