# K041416: Exac-Temp Foley Catheter and Clini-Temp Foley Catheter

- Pathway: 510(k) (Abbreviated)
- Applicant: Deroyal
- Decided: Jul 2, 2004 after 36 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K200757: Foley Catheter with Temperature Sensor (2020), 0 descendants of its own
- K061918: Foley Catheters with Temperature Probe (2006), 0 descendants of its own

## Indications for use
DeRoyal Exac-Temp and Clini-Temp Foley Catheter with Temperature Sensors are to be used for drainage of the urinary bladder and simultaneous monitoring of temperature.

Source page: https://510kreport.com/device/K041416
Methodology: https://510kreport.com/methodology