# K971013: Chase Temperature Probe

- Pathway: 510(k) (Traditional)
- Applicant: Chase Medical, Inc.
- Decided: Oct 28, 1997 after 222 days
- Product code: DTN (Reservoir, Blood, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4400
- 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 K813271 (1981). 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)
- K813271: Temperature Probes, Webster Laboratories, Inc. (1981) Summary page 1.

## Indications for use
The Temperature Probe is indicated for use during open-heart surgery to monitor myocardial temperature.

Source page: https://510kreport.com/device/K971013
Methodology: https://510kreport.com/methodology