510(k) Report

FDA applicant

Tristan Technologies, Inc.

San Diego, CA3 decisions2014–20160 recalls

FDA records 3 decisions for Tristan Technologies, Inc. (San Diego, CA) from 2014 to 2016: 3 510(k) clearances. Most are in product codes OLY (Magnetoencephalograph) and DPS (Electrocardiograph). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Tristan Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2016

2014: 12016: 2
2014high 2 (2016) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Tristan Technologies, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OLYMagnetoencephalograph2decisions
  • DPSElectrocardiograph1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K151135Model 621/624 BiomagnetometerTristan Technologies, Inc. · 20161cites it

What has FDA decided for it lately?

  • K152184MagView BIOMAGNETOMETER SYSTEMTristan Technologies, Inc. · 2016
  • K151135Model 621/624 BiomagnetometerTristan Technologies, Inc. · 2016
  • K133419Babymeg Biomagnetometer SystemTristan Technologies, Inc. · 2014

All 3 as Tristan Technologies, Inc. →