510(k) Report

FDA applicant

Zyto Technologies, Inc.

Lindon, UT1 decision2011–20112 recalls

FDA records 1 decision for Zyto Technologies, Inc. (Lindon, UT) in 2011: 1 510(k) clearance. All are in product code GZO (Device, Galvanic Skin Response Measurement). Its devices cite 1 predicate, 0 of them its own earlier devices. 2 recalls are 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 Zyto Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2011: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

2in 2015

2015: 2
2011high 2 (2015) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Zyto Technologies, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GZODevice, Galvanic Skin Response Measurement1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K111308Zyto Hand CradleZyto Technologies, Inc. · 20112 recalls

The one decision as Zyto Technologies, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K111308The ZYTO Tower is the input device to program the software with various virtual items.Nov 23, 2015Class II
  • K111308The ZYTO Select and ZYTO Elite software programs are used to rank pairs of galvanic skin…Nov 23, 2015Class II