510(k) Report

FDA applicant

Iotamotion, Inc.

Iowa City, IA2 decisions2021–20260 recalls

FDA records 2 decisions for Iotamotion, Inc. (Iowa City, IA) from 2021 to 2026: 1 510(k) clearance and 1 De Novo grant. All are in product code QQH (Powered Insertion System For A Cochlear…). Its devices cite 1 predicate, 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, ear, nose and throat panel, where it files most

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

FDA decisions per year

1in 2021

2021: 12026 (partial year): 1
2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Iotamotion, Inc. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QQHPowered Insertion System For A Cochlear Implant Electrode Array2decisions

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • DEN190055iotaSOFT Insertion System - Drive Unit, Controller and AccessoriesIotamotion, Inc. · 20211cites it

What has FDA decided for it lately?

  • K252339iotaSOFT® Insertion SystemIotamotion, Inc. · 2026
  • DEN190055iotaSOFT Insertion System - Drive Unit, Controller and AccessoriesIotamotion, Inc. · 2021

All 2 as Iotamotion, Inc. →