# P970051: Nucleus 24 Cochlear Implant System

- Pathway: PMA
- Applicant: Cochlear Americas
- Decided: Jun 25, 1998 after 234 days
- Product code: MCM (Implant, Cochlear)
- Device class: 3
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Jun 5, 2015 · Class II · Z-2155-2015: 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: Cochlear implant may shut down and cease to function.
- Sep 30, 2009 · Not classified · Z-0119-2010: Cochlear implant device component was mis-labeled.

Source page: https://510kreport.com/device/P970051
Methodology: https://510kreport.com/methodology