510(k) · Cleared
ClearediotaSOFT® Insertion System
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
Cleared on Jan 9, 2026 as substantially equivalent to DEN190055 (Iotamotion, Inc., 2021) after a 165-day review. Its family tree reaches back 1 generation to 2021.
- Decided
- Jan 9, 2026
- Review
- 165 days
- Class
- Class II
- Product code
- QQH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN190055 (2021). No later device cites it as a predicate yet.
- Root · 1 generation backDEN190055 iotaSOFT Insertion System - Drive Unit, Controller and AccessoriesIotamotion, Inc. · 2021
- This deviceK252339 iotaSOFT® Insertion SystemIotamotion, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN190055 | iotaSOFT Insertion System - Drive Unit, Controller and Accessories | Iotamotion, Inc. | 2021 | — |
| 0 (this device) | K252339 | iotaSOFT® Insertion System | Iotamotion, Inc. | 2026 | — |
Sources: FDA 510(k) 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN190055 | iotaSOFT Insertion System - Drive Unit, Controller and AccessoriesSummary page 5…PER 807.92(a)(3)] Predicate Device Name: iotaSOFT Insertion System – Drive Unit, Controller and Accessories Manufacturer: iotaMotion, Inc. Submission Number: DEN190055 This predicate has not been subject to a design-related recall. The subject device is identical to the predicate in design,… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
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. 2026, 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 array insertion. The iotaSOFT Insertion System is indicated for use in cochlear implant patients ages 4 years and older during cochlear implant procedures using either a round window or cochleostomy approach.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K252339 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252339: iotaSOFT® Insertion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252339
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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