# K193582: SterilContainer S2 System

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Mar 17, 2020 after 85 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: 5 generations back to K871202 (1987). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182414: Aesculap® SterilContainer (TM) S2 System, Aesculap, Inc. (2019) Summary page 6.
- K162815: SterilContainer S System, Aesculap, Inc. (2017) Summary page 6.
- K112671: Sterilcontainer System, Aesculap, Ltd. (2012) Summary page 6.

## Indications for use
The Aesculap SterilContainer™ S2 System is a reusable rigid sterilization container system intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed device and also maintain sterility of the enclosed device until used. This container system is compatible for use in the following sterilization modalities: • Ethylene Oxide • STERRAD 100NX DUO cycle • STERIZONE VP4 The Aesculap SterilContainer S2 System includes accessories such as silicone mats and organizers, stainless steel baskets, trays, holders, sterilization indicator cards and tamper proof locks. The attached table identifies the validated load configurations for each of the modalities.

Source page: https://510kreport.com/device/K193582
Methodology: https://510kreport.com/methodology