510(k) Report

FDA applicant

Iti Medical Technologies, Inc.

Livermore, CA2 decisions1997–19983 recalls

FDA records 2 decisions for Iti Medical Technologies, Inc. (Livermore, CA) from 1997 to 1998: 2 510(k) clearances. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 3 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Iti Medical Technologies, Inc. since 2007.

Recalls per year

1in 2012

2009: 12012: 1
2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Iti Medical Technologies, 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?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories2decisions

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 2 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.

  • K982705Midas Touch Bipolar ForcepsIti Medical Technologies, Inc. · 19982cite it

What has FDA decided for it lately?

  • K982705Midas Touch Bipolar ForcepsIti Medical Technologies, Inc. · 19981 recall
  • K973234Midas Touch Electrosurgical ElectrodeIti Medical Technologies, Inc. · 19972 recalls

All 2 as Iti Medical Technologies, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K982705Bayonet Forceps 8.5" (215.9mm) Serrated 1.0 mm Tips Electrosurgical/Monopolar…Jun 1, 2012Class II
  • K973234Olsen Medical, MIDAS TOUCH NEEDLE ELECTRODE, WITH MODIFIED TIP. Model Numbers: 30-1011…Sep 24, 2009
  • K973234MIDAS TOUCH Electrosurgical/102 mm (4 inch) Blade Electrodes, Disposable, Sterile Single…Aug 29, 2006