510(k) Report

FDA applicant

Iomed, Inc.

Salt Lake City, UT17 decisions1990–20070 recalls

FDA records 17 decisions for Iomed, Inc. (Salt Lake City, UT) from 1990 to 2007: 17 510(k) clearances. Most are in product codes EGJ (Device, Iontophoresis, Other Uses) and KTB (Device, Iontophoresis, Specific Uses). Its devices cite 11 predicates, 9 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, physical medicine panel, where it files most

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

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Iomed, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • EGJDevice, Iontophoresis, Other Uses11decisions
  • KTBDevice, Iontophoresis, Specific Uses6decisions

Whose devices does it build on?

Its devices cite 11 predicates; 9 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 34 times; 9 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.

  • K932620RH-806/GS Model Transq (R)2Iomed, Inc. · 19946cite it
  • K932621RH-801/GS Model Transq (R)1Iomed, Inc. · 19946cite it
  • K982668Phoresor II,Model PM900Iomed, Inc. · 19994cite it
  • K974855Phoresor II, Model PM900Iomed, Inc. · 19984cite it
  • K934335Phoresor II Auto, Model PM800 ModificationIomed, Inc. · 19943cite it
  • K914621Iontophoresis Device, ModificationIomed, Inc. · 19912cite it

What has FDA decided for it lately?

  • K063465Champion Iontophoretic Drug Delivery DeviceIomed, Inc. · 2007
  • K060236MW-1000 Iontophoretic Drug Delivery ElectrodeIomed, Inc. · 2006
  • K033192RH-950Iomed, Inc. · 2003
  • K031115RH-900Iomed, Inc. · 2003
  • K001522TRANSQ3Iomed, Inc. · 2000
  • K001410Phoresor Model PM2000Iomed, Inc. · 2000
  • K982668Phoresor II,Model PM900Iomed, Inc. · 1999
  • K974855Phoresor II, Model PM900Iomed, Inc. · 1998

All 17 as Iomed, Inc. →