PMA · Approved
ApprovedCombi 40+ Cochlear Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Med-El Corp. · MCM Implant, Cochlear
Approved on Apr 24, 2025 through premarket approval, which rests on the device’s own clinical evidence after a 30-day review.
- Decided
- Apr 24, 2025
- Review
- 30 days
- Class
- Class III
- Product code
- MCM
- Recalls
- None
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MCM? 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
Does it have a predicate?
PMA decisions do not claim a predicate device.
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.
How does its category compare?
All MCM devicesMCM Implant, Cochlear: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
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 | — |
https://510kreport.com/device/P000025/S135 · printed Nov 6, 2026
Cite this page
510(k) Report. “P000025/S135: Combi 40+ Cochlear Implant System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P000025/S135
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026