510(k) Report

FDA applicant

Idmed

Marseille, FR3 decisions2018–20250 recalls

FDA records 3 decisions for Idmed (Marseille, FR) from 2018 to 2025: 3 510(k) clearances. Most are in product codes KOI (Stimulator, Nerve, Peripheral, Electric) and BSK (Cuff, Tracheal Tube, Inflatable). Its devices cite 3 predicates, 1 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, anesthesiology panel, where it files most

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

FDA decisions per year

2in 2025

2018: 12025: 2
2018high 2 (2025) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Idmed by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KOIStimulator, Nerve, Peripheral, Electric2decisions
  • BSKCuff, Tracheal Tube, Inflatable1decision

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K172690ToFscanIdmed · 20183cite it

What has FDA decided for it lately?

All 3 as Idmed →