FDA product code · Ear, nose and throat
Implant, Cochlear
8 FDA decisions since 1984. 20 recalls name this code, 0 of them Class I.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of MCM 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 · MCM
17in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MCM
Too few MCM 510(k)s in any year since 2007 to give a median.
Recalls per year · MCM
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MCM
5,418in 2025
MAUDE reports naming product code MCM, 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 | 17 | — | 1 | 1,639 |
| 2008 | 17 | — | 4 | 1,793 |
| 2009 | 19 | — | 2 | 1,897 |
| 2010 | 21 | — | 2 | 1,773 |
| 2011 | 27 | — | 1 | 2,293 |
| 2012 | 21 | — | 0 | 3,078 |
| 2013 | 28 | — | 0 | 2,689 |
| 2014 | 23 | — | 0 | 2,676 |
| 2015 | 23 | — | 0 | 3,105 |
| 2016 | 25 | — | 0 | 2,785 |
| 2017 | 31 | — | 0 | 3,122 |
| 2018 | 20 | — | 0 | 3,054 |
| 2019 | 35 | — | 0 | 3,405 |
| 2020 | 25 | — | 2 | 4,403 |
| 2021 | 20 | — | 0 | 5,260 |
| 2022 | 24 | — | 0 | 5,502 |
| 2023 | 18 | — | 0 | 5,727 |
| 2024 | 17 | — | 0 | 5,602 |
| 2025 | 17 | — | 0 | 5,418 |
| 2026 | 13 | — | 2 | — |
Planning a device in MCM? 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