FDA product code QQH: Powered Insertion System For A Cochlear Implant Electrode Array
QQH is the FDA product code for powered insertion system for a cochlear implant electrode array. It is a Class II device, regulated under 21 CFR 874.4450 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 1 510(k) submission under QQH, 1 in the last five years. The average 510(k) review took 165 days (median 165); 165 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 1 recall for QQH devices, 1 initiated in the last five years.
Definition
A powered insertion system for a cochlear implant electrode array is a prescription device used to assist in placing an electrode array into the cochlea.
Classification
| Field | Value |
|---|---|
| Device name | Powered Insertion System For A Cochlear Implant Electrode Array |
| Device class | Class II |
| Regulation | 21 CFR 874.4450 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
510(k) clearances per year for QQH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2026 | 1 | 165 |
Compare with all 510(k) review times · Search every QQH clearance
Top QQH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Iotamotion, Inc. | 1 | 2026-01-09 |
Most recent QQH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252339 | Iotamotion, Inc. | iotaSOFT® Insertion System | 2026-01-09 | 165 |
Recalls for QQH devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 0 still open. Most recent: 2024-09-12.
| Year | Recalls |
|---|---|
| 2024 | 1 |
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- L8628 — Cochlear implant, external controller component, replacement
- L8616 — Microphone for use with cochlear implant device, replacement
- L8627 — Cochlear implant, external speech processor, component, replacement
- L8615 — Headset/headpiece for use with cochlear implant device, replacement
- L8617 — Transmitting coil for use with cochlear implant device, replacement
Frequently asked questions
What is FDA product code QQH?
QQH is the FDA product code for powered insertion system for a cochlear implant electrode array. It is a Class II device, regulated under 21 CFR 874.4450 and reviewed by the Ear, Nose and Throat panel.
What device class is QQH?
Class II, regulation 21 CFR 874.4450. Typical premarket route: 510(k).
How long does a 510(k) take for product code QQH?
Across 1 cleared submissions the average was 165 days from receipt to decision (median 165).
Which companies have the most QQH clearances?
Iotamotion, Inc. (1).
Have QQH devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2024-09-12.
Next steps
- Run an FDA pathway report with predicate devices for product code QQH
- Run a recall and safety report across every QQH manufacturer
- Watch product code QQH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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