# K020365: 3TM Myocardial Needle-Temperature Probe

- Pathway: 510(k) (Traditional)
- Applicant: 3t Medical Systems, LLC
- Decided: May 3, 2002 after 88 days
- Product code: KRI (Accessory Equipment, Cardiopulmonary Bypass)
- Device class: 1
- Regulation: 21 CFR 870.4200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The 3T Myocardial Needle Temperature Probes are indicated for use in the routine monitoring of temperature during open-heart surgery and is intended for insertion into the myocardium,

Source page: https://510kreport.com/device/K020365
Methodology: https://510kreport.com/methodology