Class Class II
Aesculap AICON Container (K214041)
Description
Aesculap AICON Container by Aesculap, Inc., an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK214041
Clearance Date2022-12-30
Clearance TypeTraditional
Product CodeKCT
Regulation Number880.6850
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K214041
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Aesculap AICON Container (K214041) cites 3 predicate devices and is itself cited by 4 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K192056 | JJ Series Container System | Aesculap, Inc. | 2020 |
| K193582 | SterilContainer S2 System | Aesculap, Inc. | 2020 |
| K182414 | Aesculap® SterilContainer(TM) S2 System | Aesculap, Inc. | 2019 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K242762 | Aesculap Aicon® Series Container System | Aesculap, Inc. | 2025 |
| K250029 | ONE TRAY® Sealed Sterilization Container System | Innovative Sterilization Technologies | 2025 |
| K242834 | System 9 Sterile Battery Container | Stryker Instruments | 2025 |
| K233578 | BAHADIR STERILIZATION CONTAINERS | Bahadir USA, LLC | 2024 |
Trace the full predicate network for K214041
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.