# K231604: Instrument Case

- Pathway: 510(k) (Special)
- Applicant: Cochlear Americas
- Decided: Aug 24, 2023 after 84 days
- Product code: KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K844002 (1984). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223672: Instrument Case P1340904, Cochlear (2023) Summary page 4.

## Indications for use
The Instrument Case is intended for staff involved in reprocessing of reusable instruments, and for surgical teams. The product shall only be used: • in a controlled surgical environment under sterile conditions such as a hospital, • in reprocessing environment at sterilization departments or reprocessing centers, • and for transport of surgical instruments. Sterilization parameters: In US: Pre-Vacuum Steam at 132 °C (270 °F) for 4 min with a 20 minutes dry time Outside US: See the Reprocessing Guide available in your country The worse-case validated load for the Instrument Case, including instruments, is 1700 g.

Source page: https://510kreport.com/device/K231604
Methodology: https://510kreport.com/methodology