De Novo · Granted
GrantediotaSOFT Insertion System - Drive Unit, Controller and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iotamotion, Inc. · QQH Powered Insertion System For A Cochlear Implant Electrode Array
Granted on Oct 1, 2021 as a new device type through De Novo after a 653-day review. 1 later device descends from it.
- Decided
- Oct 1, 2021
- Review
- 653 days
- Class
- Class II
- Product code
- QQH
- Recalls
- None
1 later device descends from it, 1 citing it directly.
- This deviceDEN190055 iotaSOFT Insertion System - Drive Unit, Controller and AccessoriesIotamotion, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK252339 iotaSOFT® Insertion SystemIotamotion, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K252339iotaSOFT® Insertion SystemIotamotion, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN190055 | iotaSOFT Insertion System - Drive Unit, Controller and Accessories | Iotamotion, Inc. | 2021 | — |
| +1 | K252339 | iotaSOFT® Insertion System | Iotamotion, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QQH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QQH device
- #1 K252339 iotaSOFT® Insertion Systemscore 10.6 · 1 generation · no Class I recall
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252339 | iotaSOFT® Insertion System | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K252339 (Iotamotion, Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QQH devicesQQH Powered Insertion System For A Cochlear Implant Electrode Array: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · QQH
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · QQH
Too few QQH 510(k)s in any year since 2007 to give a median.
Recalls per year · QQH
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QQH
3in 2025
MAUDE reports naming product code QQH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 1 | 3 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The iotaSOFT™ Insertion System is intended to aid the surgeon in placement of cochlear implant electrode arrays into a radiographically normal cochlea by controlling the speed of implant insertion. The iotaSOFT Insertion System is intended for use in cochlear implant patients ages 12 years and older during cochlear implant procedures using either a round window or cochleostomy approach.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN190055 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN190055: iotaSOFT Insertion System - Drive Unit, Controller and Accessories.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN190055
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026