# K162063: Steri-Cassette and Steri-Cage Sterilization Packaging System

- Pathway: 510(k) (Traditional)
- Applicant: Sybron Dental Specialties
- Decided: Apr 21, 2017 after 269 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: 4 generations back to K844002 (1984). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012105: Polyvac Surgical Instrument Delivery System, Symmetry Medical, Inc. (2002) Summary page 4.

## Indications for use
The Steri-Cassettes and Steri-Cages are intended to contain dental instruments for cleaning, sterilization, organization, storage and handling. The Steri-Cassettes and Steri-Cages are suitable for pre-vacuum and gravity displacement steam sterilization methods. The cassettes and cages are not intended to maintain sterility; they are intended to be used in conjunction with validated, FDA-cleared sterilization wrap in order to maintain sterility of the enclosed devices. The validated steam sterilization cycle parameters are as follows: Steam Sterilization Cycle | Minimum Exposure Temperature | Minimum Exposure Time | Minimum Dry Time Gravity Displacement (wrapped) | 250°F (121°C) | 30 Minutes | 15 Minutes Gravity Displacement (wrapped) | 270°F (132°C) | 15 Minutes | 15 Minutes Gravity Displacement (wrapped) | 275°F (135°C) | 10 Minutes | 30 Minutes Gravity Displacement (unwrapped for immediate use) | 132°C (270°F) | 3 Minutes | None Pre-Vacuum (wrapped) | 270°F (132°C) | 4 Minutes | 30 Minutes Pre-Vacuum (wrapped) | 275°F (135°C) | 3 Minutes | 16 Minutes Pre-Vacuum (unwrapped for immediate use) | 273°F (134°C) | 3 Minutes | None

Source page: https://510kreport.com/device/K162063
Methodology: https://510kreport.com/methodology