510(k) Report

FDA applicant

Hidrex GmbH

Texas City, TX1 decision2015–20153 recalls

FDA records 1 decision for Hidrex GmbH (Texas City, TX) in 2015: 1 510(k) clearance. All are in product code EGJ (Device, Iontophoresis, Other Uses). Its devices cite 2 predicates, 0 of them its own earlier devices. 3 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, physical medicine panel, where it files most

How often FDA has decided Hidrex GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

3in 2017

2017: 3
2015high 3 (2017) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Hidrex GmbH by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • EGJDevice, Iontophoresis, Other Uses1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 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.

  • K133033Hidrex PSP1000Hidrex GmbH · 20153cite it

What has FDA decided for it lately?

  • K133033Hidrex PSP1000Hidrex GmbH · 20153 recalls

The one decision as Hidrex GmbH →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K133033Daavlin Aquex (DAAV1000)Jan 30, 2017Class III
  • K133033Hidrex USA DVP1000Jan 30, 2017Class III
  • K133033Hidrex USA DP450Jan 30, 2017Class III