# K142970: SterilContainer S System

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Jul 8, 2015 after 267 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: 2 generations back to K040865 (2004). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093493: Aesculap Sterilcontainer S, Aesculap, Inc. (2010) Summary page 5.

## Indications for use
The SterilContainer S System is a reusable sterilization container system (consisting of perforated bottoms and perforated lids with filter retention plates, and single-use polypropylene filters) intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. This container system has been validated with hinged, and knurled instruments. 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 with STERRAD 100NX EXPRESS Cycle. The SterilContainer S System includes accessories such as silicone mats, baskets, trays, racks, eyepiece holders and sleeve holders. Testing has been completed on the SterilContainer S Full size container to maintain the sterility of its contents for 360 days following successful sterilization. Testing has been completed on the SterilContainer S ½ size container to maintain the sterility of its contents for 30 days following successful sterilization. The validated chamber load for the SterilContainer S Full and Half sizes in the STERRAD 100NX EXPRESS Cycle consisted of one SterilContainer S placed on the bottom shelf in an otherwise empty chamber.

Source page: https://510kreport.com/device/K142970
Methodology: https://510kreport.com/methodology