# K160091: Temperature Probe, Affinity Temperature Probe

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: May 20, 2016 after 126 days
- Product code: FLL (Continuous Measurement Thermometer)
- Device class: 2
- Regulation: 21 CFR 880.2910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K936003 (1994). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100645: Affinity Pixie Oxygenation System with Carmeda Bioactive Surface or Balance Biosurface, Medtronic, Inc. (2012) Summary page 4.
- K831528: Model TP Thermistor Probe, Scimed Life Systems, Inc. (1983) Summary page 4.

## Indications for use
The temperature probe is intended for use for continuous blood temperature monitoring as measured at a temperature monitoring adapter located within a Medtronic extracorporeal circulation device as specified in the device's instructions for use. The temperature probe is designed for use with a YSI tele-thermometer to monitor and display temperature.

Source page: https://510kreport.com/device/K160091
Methodology: https://510kreport.com/methodology