# K182414: Aesculap® SterilContainer (TM) S2 System

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Jul 5, 2019 after 304 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: 1 generation back to K792558 (1979). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K792558: Container System, Aesculap Instruments Corp. (1979) Summary page 9.

## Most influential descendants
- K193582: SterilContainer S2 System (2020), 0 descendants of its own

## Indications for use
The Aesculap(R) 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: • Dynamic-air removal steam (PreVac) (Exposure: 270°F for 4 minutes with 15 minute dry time) • Gravity Steam (Exposure: 250°F for 30-60 minutes with 15 minute dry time) • STERRAD 100S, STERRAD NX Standard, STERRAD NX Advanced, STERRAD 100NX Standard, STERRAD 100NX Flex Cycles • STERIS V-PRO 60 Lumen, V-PRO 60 Non-Lumen, V-PRO 60 Flex, V-PRO maX Lumen, V-PRO maX Non-Lumen, and V-PRO maX Flex Cycles. 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/K182414
Methodology: https://510kreport.com/methodology