# K053389: Aesculap Sterilcontainer System

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Feb 15, 2006 after 72 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: 2 generations back to K871202 (1987). 6 ancestors in all.
12 later devices descend from it; 4 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022978: Steritite Container with Flashtite Valve Plate (S) & Meditray Products, Case Medical, Inc. (2003) Summary page 1.
- K871202: Flashpak Container System, Performance Instruments Corp. (1987) Summary page 1.
- K792558: Container System, Aesculap Instruments Corp. (1979) Summary page 1.

## Most influential descendants
- K073168: Aesculap Primeline Container LTD. (2008), 9 descendants of its own
- K112671: Sterilcontainer System (2012), 7 descendants of its own
- K192056: JJ Series Container System (2020), 5 descendants of its own
- K214041: Aesculap AICON Container (2022), 4 descendants of its own
- K131407: Bahadir Sterilization Trays (2014), 1 descendant of its own

## Indications for use
The Aesculap Sterilcontainer is a reusable sterilization container system (consisting of a solid bottom, a perforated lid w/ filter retention plates, and disposable paper filters) 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 has been validated with stainless steel lumens, hinged, and knurled instruments (stainless steel lumens of greater than 3 mm inner diameter or less than 400 mm in length). This container system is compatible for use in pre-vacuum (steam) flash sterilization. The SterilContainer System for includes accessories such as baskets, trays, and racks. The following containers (lids & bottoms) were validated for pre-vacuum Flash sterilization: Full Size: Lid JK489/ Bottoms JK440, JK441, JK442, and JK444 Three-Quarter Size: Lid JK789/ Bottoms JK740, JK741, and JK742 Half Size: Lid JK389/ Bottoms JK339, JK340, JK341, JK342, and JK344 Mini Containers: Lid JK174/ Bottoms JK187 and JK188

Source page: https://510kreport.com/device/K053389
Methodology: https://510kreport.com/methodology