FDA product code · Ear, nose and throat
Powered Insertion System For A Cochlear Implant Electrode Array
2 FDA decisions since 2021. 1 recall names this code; it is not Class I. The most-cited predicate is DEN190055, named by 1 later device.
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.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of QQH at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
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 | — |
Planning a device in QQH? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report