# K061918: Foley Catheters with Temperature Probe

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Aug 18, 2006 after 43 days
- Product code: EYC (Catheter, Upper Urinary Tract)
- 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 K041416 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041416: Exac-Temp Foley Catheter and Clini-Temp Foley Catheter, Deroyal (2004) Summary page 2.

## Indications for use
Foley catheters with temperature probe (REF M1024239, M1024242 and M1024244): The Foley Catheter with Temperature Probe is intended for continuous temperature monitoring of patients who are catheterized because of fluid management problems, evaluation of urinary output, urine clearance following surgery or trauma involving pelvic organs, or obstruction or paralysis. Maximum indwelling: 29 days. The temperature probes are designed for use with Datex-Ohmeda and GE Medical Systems IT monitoring systems and other monitors compatible with 400 Series temperature probes. Please consult your monitoring system manual for information specific to temperature probes usage. The device is indicated for use by qualified medical personnel only.

Source page: https://510kreport.com/device/K061918
Methodology: https://510kreport.com/methodology