# K112671: Sterilcontainer System

- Pathway: 510(k) (Special)
- Applicant: Aesculap, Ltd.
- Decided: May 4, 2012 after 233 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: 4 generations back to K871202 (1987). 12 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073168: Aesculap Primeline Container LTD., Aesculap, Inc. (2008) Summary page 1.
- K053389: Aesculap Sterilcontainer System, Aesculap, Inc. (2006) Summary page 3.
- K944864: Primed Rigid Container System, Primed, Inc. (1994) Summary page 3.
- K792558: Container System, Aesculap Instruments Corp. (1979) Summary page 1.

## Most influential descendants
- K192056: JJ Series Container System (2020), 5 descendants of its own
- K214041: Aesculap AICON Container (2022), 4 descendants of its own
- K242762: Aesculap Aicon® Series Container System (2025), 0 descendants of its own
- K250029: ONE TRAY® Sealed Sterilization Container System (2025), 0 descendants of its own
- K242834: System 9 Sterile Battery Container (2025), 0 descendants of its own

## Indications for use
The Aesculap SterilContainer System is a reusable 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 for 360 days. The SterilContainer System includes accessories such as mats, baskets, trays, holders, organizers, filters, indicator cards and tamper proof locks. The container system consists of a three-quarter size, 8" tall perforated (JN744) or solid (JK744) aluminum bottom and a three-quarter size aluminum or PrimeL-ine lid. The lids are available in different colors to aide in set recognition. There are three types of filter materials. A single use paper filter (US751, US9S4), a single use polypropylene filter (MD344), and a reusable PTIFE filter (JKO9O). The reusable PTFE is validated for 2200 uses. There are a variety of accessories for use with the container system. Please refer to the chart on the next page for sterilization compatibility of the container system.

Source page: https://510kreport.com/device/K112671
Methodology: https://510kreport.com/methodology