# K093493: Aesculap Sterilcontainer S

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Jul 27, 2010 after 259 days
- Product code: FRG (Wrap, Sterilization)
- 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 K040865 (2004). 2 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040865: Aesculap Sterrad 100S Compatable Sterilcontainer, Aesculap (2004) Summary page 1.
- K080558: Steritite Container System & Meditray Products, Case Medical, Inc. (2008) Summary page 1.

## Most influential descendants
- K110682: Steritite Container System & Meditray Products (2011), 1 descendant of its own
- K182032: SterilContainer S System (2018), 0 descendants of its own
- K161415: SteriTite Containers System & MediTray Products (2017), 0 descendants of its own
- K142970: SterilContainer S System (2015), 0 descendants of its own

## Indications for use
The Aesculap Sterilcontainer S is a reusable sterilization container system (consisting of perforated bottoms and perforated lids with filter retention plates, and disposable polypropylene filters) intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. This container has been validated with stainless steel lumens, 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 the STERRAD 200, STERRAD NX (Standard cycle and Advanced cycle), and STERRAD 100ONX (Standard cycle and Flex cycle). The Sterilcontainer S System includes accessories such as silicone mats, baskets, trays, racks, eyepiece holders and sleeve holders. The Steriicontainer S is recommended for surface and lumens: STERRAD 200, stainless steel lumens Ž:3mm I.D. x!•400mm L STERRAD NX standard cycle, stainless steel lumens Ž 2mm I.D. x S400mm L STERRAD NX advanced cycle, stainless steel lumens Ž 1mm l.D. x S 500mm L STERRADI1 ONX standard cycle, stainless steel lumens Ž0.7mm l.D. x 5500mm L STERRAD 1 ONX flex cycle, porous lumens (flexible endoscope) Žlmm1.0. x S850mm L 30 days of shelf life testing has been conducted for the Sterilicontainer S. The attached tables identify which products may be sterilized in which STERRAD sterilization cycle.

Source page: https://510kreport.com/device/K093493
Methodology: https://510kreport.com/methodology