# K073168: Aesculap Primeline Container LTD.

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Apr 28, 2008 after 171 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: 3 generations back to K871202 (1987). 11 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053389: Aesculap Sterilcontainer System, Aesculap, Inc. (2006) Summary page 1.
- K041623: Reusable Sterilcontainer Filter Model #JK090, Aesculap, Inc. (2004) Summary page 1.
- K944864: Primed Rigid Container System, Primed, Inc. (1994) Summary page 1.
- K792558: Container System, Aesculap Instruments Corp. (1979) Summary page 1.

## Most influential descendants
- 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
- 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

## Indications for use
The Aesculap Sterilcontainer System is a reusable sterilization container system (consisting of solid and perforated bottoms, a perforated lid w/ filter retention plates, and reusable polytetrafluoroethylene 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 system is compatible for use in pre-vacuum steam and flash sterilization. The SterilContainer System includes accessories such as silicon mats, baskets, trays, and racks. A combined maximum load validated for all container configurations is 351bs.

Source page: https://510kreport.com/device/K073168
Methodology: https://510kreport.com/methodology