Iotamotion Inc

FDA Regulatory Profile

Iotamotion Inc appears in FDA public data with 1 recall, 2 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-0288-2025, Class III) was initiated on September 12, 2024. Its most recent 510(k) clearance was granted on January 9, 2026.

Summary

Total Recalls
1
510(k) Clearances
2
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0288-2025Class IIIiotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended to aid the surgeon inSeptember 12, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K252339iotaSOFT® Insertion SystemJanuary 9, 2026
DEN190055iotaSOFT Insertion System - Drive Unit, Controller and AccessoriesOctober 1, 2021