# K090818: Karl Storz -Endoscope Sterilization Trays, Models 39402AS, 39301HCTS, 39301BS

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Aug 18, 2009 after 146 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
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K112536: Sonicision Sterilization Tray (2012), 2 descendants of its own
- K131170: Sonicision Sterilization Tray (2013), 1 descendant of its own
- K201945: KARL STORZ UDEL Sterilization Trays (2021), 0 descendants of its own
- K151347: MIS Spine Frame Instrument Case (2015), 0 descendants of its own

## Indications for use
The KARL STORZ-ENDOSKOPE Sterilization Trays are intended only for use to encase and protect specific KARL STORZ reusable medical devices for sterilization in STERRAD 100S and NX Sterilization Systems, as indicated. STERRAD Sterilization Systems are pre-set and the cycle parameters can not be adjusted.

Source page: https://510kreport.com/device/K090818
Methodology: https://510kreport.com/methodology