Iotamotion, Inc.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Iotamotion, Inc.” (first 2026, latest 2026), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 165 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2026 | 1 | 165 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Iotamotion, Inc. took a median 165 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 165 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QQH | Powered Insertion System For A Cochlear Implant Electrode Array | 2 | 1 |
Review panels
Most recent Iotamotion, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252339 | iotaSOFT® Insertion System | QQH | 2026-01-09 | 165 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN190055 | De Novo | Powered Insertion System For A Cochlear Implant Electrode Array | 2021-10-01 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2024-09-12.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Iotamotion, Inc. is the lead sponsor of 4 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT06664697: Post-Market Clinical Investigation of the IotaSOFT Insertion System (Recruiting, started 2024-10-01)
- NCT06664710: Evaluation of the Automated Integration of a Robotics and ECochG System for Use With Cochlear Implant Surgery (Recruiting, started 2024-01-17)
- NCT06106373: iotaSOFT Pediatric Study (Completed, started 2022-05-17)
- NCT04577118: The iotaSOFT Insertion System Safety Study (Completed, started 2020-09-18)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Iotamotion, Inc. (a text match, not an official crosswalk):
- L8616 — Microphone for use with cochlear implant device, replacement (via QQH)
- L8628 — Cochlear implant, external controller component, replacement (via QQH)
Frequently asked questions
How many FDA 510(k) clearances are listed under Iotamotion, Inc.?
FDA lists 1 510(k) clearance under the applicant name “Iotamotion, Inc.” (first 2026, latest 2026), plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Iotamotion, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Iotamotion, Inc. is 165 days.
Which FDA product codes appear under Iotamotion, Inc.?
The most frequent FDA product codes under this applicant name are QQH (Powered Insertion System For A Cochlear Implant Electrode Array, 2).
Next steps
- See all 1 Iotamotion, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QQH, Iotamotion, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.