PMA · Approved

Recalled · Class II · 2015

Nucleus 24 Cochlear Implant System

P970051PMAApproved Jun 25, 1998234-day reviewClass IIIRecalls 3

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cochlear Americas · MCM Implant, Cochlear

Approved on Jun 25, 1998 through premarket approval, which rests on the device’s own clinical evidence after a 234-day review. It has been recalled 3 times.

Decided: Jun 25, 1998
Review: 234 days
Class: Class III
Product code: MCM
Recalls: 3

PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.

P970051 has 225 supplements since 1998: changes to the approved device, its labelling or its manufacturing, each approved separately.

PMA supplements approved per year

1998high 17 (2011) · low 1 (2004)2026

View FIG. 1 as a table

Year	Supplements approved
1998	3
1999	5
2000	3
2001	5
2002	7
2003	3
2004	1
2005	5
2006	5
2007	5
2008	2
2009	6
2010	9
2011	17
2012	6
2013	14
2014	12
2015	12
2016	17
2017	17
2018	10
2019	9
2020	12
2021	5
2022	10
2023	7
2024	8
2025	8
2026	2

FIG. 1 — Supplements to P970051, 1998–2026Source: FDA PMA database

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

Get a 510(k) 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)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 5, 2015	Class II	Z-2155-2015	Process control	Cochlear Americas is recalling Nucleus Sterile Silicone Template CI24RE/CI422 part number Z421736 because expired product was distributed.
Sep 16, 2011	Not classified	Z-0003-2012	Component design/selection	Cochlear implant may shut down and cease to function.
Sep 30, 2009	Not classified	Z-0119-2010	Labeling mix-ups	Cochlear implant device component was mis-labeled.

No ancestor or descendant has a Class I recall.

How does its category compare?

All MCM devices

MCM Implant, Cochlear: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MCM

17in 2025

2007high 35 (2019) · low 17 (2007)2026

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

2007high 4 (2008) · low 0 (2012)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MCM

5,418in 2025

2007high 5,727 (2023) · low 1,639 (2007)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/P970051 · printed Nov 6, 2026

Cite this page

510(k) Report. “P970051: Nucleus 24 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/P970051

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Record history

FDA decision record loaded May 2, 2026
Page last updated Nov 3, 2026