510(k) Report

FDA applicant

Impeto Medical, Inc.

Alexandria, VA2 decisions2010–20140 recalls

FDA records 2 decisions for Impeto Medical, Inc. (Alexandria, VA) from 2010 to 2014: 2 510(k) clearances. All are in product code GZO (Device, Galvanic Skin Response Measurement). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Impeto Medical”.

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 Impeto Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2010: 12014: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Impeto Medical, Inc. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Impeto Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • GZODevice, Galvanic Skin Response Measurement2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 1 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.

  • K100233SudoscanImpeto Medical · 20103cite it
  • K141872SudoscanImpeto Medical, Inc. · 20141cites it

What has FDA decided for it lately?

  • K141872SudoscanImpeto Medical, Inc. · 2014
  • K100233SudoscanImpeto Medical · 2010

The one decision as Impeto Medical, Inc. →The one decision as Impeto Medical →