# K151135: Model 621/624 Biomagnetometer

- Pathway: 510(k) (Traditional)
- Applicant: Tristan Technologies, Inc.
- Decided: Mar 15, 2016 after 321 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- 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 K901215 (1990). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033488: Cmi Magnetocardiograph, Cmi Cardiomag Imaging, Inc. (2004) Summary page 6.

## Most influential descendants
- K182571: CardioFlux with Faraday Analytical Cloud (2019), 0 descendants of its own

## Indications for use
The Tristan Technologies Model 621/624 Biomagnetometer is intended for use as a tool that non-invasively measures and displays the magnetic signals produced by the electric currents in the heart of human beings of any age or in the heart of a fetus in utero.

Source page: https://510kreport.com/device/K151135
Methodology: https://510kreport.com/methodology