# K242834: System 9 Sterile Battery Container

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Instruments
- Decided: Jan 16, 2025 after 119 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: 7 generations back to K871202 (1987). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K214041: Aesculap AICON Container, Aesculap, Inc. (2022) Summary page 6.

## Indications for use
The Stryker System 9 Sterile Battery Container is a reusable rigid sterilization container intended to allow for sterilization, by hospitals, surgery centers, and healthcare facilities, of the enclosed, compatible Stryker Sterile Battery Packs and maintain sterility of the enclosed device until used. The container is validated for use with compatible battery packs in low temperature hydrogen peroxide sterilization cycles. Validated Low Temperature Hydrogen Peroxide Sterilization Cycles: Load Configuration Cycles System 9 Sterile Battery Container Bundle, Small: STERRAD NX Standard cycle STERRAD 100NX Standard cycle STERRAD 100S short cycle Steris V-PRO maX Lumen cycle Steris V-PRO maX 2 Lumen cycle Steris V-PRO 60 Lumen cycle Steris V-PRO s2 Lumen cycle System 9 Sterile Battery Container Bundle, Large: STERRAD NX Standard cycle STERRAD 100NX Standard cycle STERRAD 100S short cycle Steris V-PRO maX Lumen cycle Steris V-PRO maX 2 Lumen cycle Steris V-PRO 60 Lumen cycle Steris V-PRO s2 Lumen cycle

Source page: https://510kreport.com/device/K242834
Methodology: https://510kreport.com/methodology