# K242762: Aesculap Aicon® Series Container System

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: May 13, 2025 after 243 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: 7 generations back to K871202 (1987). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K214041: Aesculap AICON Container, Aesculap, Inc. (2022) Summary page 17.

## 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 • STERIS V-PRO S2 Non-Lumen • STERRAD 100NX: Standard, Express, Flex, Duo • STERRAD NX: Standard, Advanced • STERRAD 100S • STERIZONE VP4 • PreVac Steam The AESCULAP Aicon® consists of two different container styles: a solid bottom container and enhance drying system (EDS) container. The AESCULAP Aicon® Container is compatible with accessories such as baskets, trays, instrument organizational accessories, holders, indicator cards, tamper evident locks, lid covers, faceplate holders, and tags. Prevac cycles without dry times are Immediate Use Sterilization Cycles (IUSS). The following tables identify the load configurations. Table 1. AESCULAP Aicon® Container Lumen Configurations Sterilization IOS Container Configuration Compatible Lumens Cycle Sizes Ethylene Oxide (EtO) Full Size (2) Stainless Steel Lumens (≥3.0mm ID x ≤ 400mm L) (130°F, 60 minute If including silicone, Three-Quarter Size (2) Stainless Steel Lumens (≥3.0mm ID x ≤ 400mm L) exposure stainless steel, or no 50-70% RH, IOS: Half Size (2) Stainless Steel Lumens (≥3.0mm ID x ≤ 400mm L) concentration 735mg/L) (6) Stainless Steel Lumens (≥1mm ID x ≤ 400mm L) Full Size STERIS V-PRO maX (6) Stainless Steel Lumens (≥0.77mm ID x ≤ 250mm L) Only stainless steel or (6) Stainless Steel Lumens (≥1mm ID x ≤ 400mm L) /maX 2 no IOS: Three-Quarter Size Lumen Cycle (6) Stainless Steel Lumens (≥0.77mm ID x ≤ 250mm L) Half Size (12) Stainless Steel Lumens (≥1mm ID x ≤ 150mm L) STERIS V-PRO Max/ If including silicone, Full Size Non lumened stainless steel instruments Max 2 stainless steel, or no Three-Quarter Size Non lumened stainless steel instruments Non-Lumen Cycle IOS: Half Size Non lumened stainless steel instruments STERIS V-PRO maX / (1) Flexible endoscope with a light cord (if not integral Only stainless steel or maX 2 Full Size to no IOS: Flex Cycle endoscope) without any additional load. The flexible

Source page: https://510kreport.com/device/K242762
Methodology: https://510kreport.com/methodology