# K214041: Aesculap AICON Container

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Dec 30, 2022 after 372 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: 6 generations back to K871202 (1987). 14 ancestors in all.
4 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)
- K192056: JJ Series Container System, Aesculap, Inc. (2020) Summary page 12.

## Most influential descendants
- 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
- K233578: Bahadir Sterilization Containers (2024), 0 descendants of its own

## Indications for use
The AESCULAP Aicon™ Container is a reusable rigid sterilization container 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 during transport and until used. This container is compatible for use in the following sterilization modalities in the configurations listed below: • Ethylene Oxide (EtO) • STERIS V-PRO maX/maX 2: Lumen, Non-Lumen, Flex • STERIS V-PRO 60: Lumen, Non- Lumen, Flex • STERRAD 100NX: Standard, Express, Flex, Duo • STERRAD NX: Standard, Advanced • STERRAD l00S • STERIZONE VP4 • PreVac Steam The AESCULAP Aicon™ consists of two different container styles: a solid bottom container and enhanced drying system (EDS) container. The following tables identify the load configurations.

Source page: https://510kreport.com/device/K214041
Methodology: https://510kreport.com/methodology