510(k) · Cleared
ClearedAesculap AICON Container
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Dec 30, 2022 as substantially equivalent to K192056 (Aesculap, Inc., 2020) after a 372-day review. Its family tree reaches back 6 generations to 1987. 4 later devices descend from it.
- Decided
- Dec 30, 2022
- Review
- 372 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K871202 (1987). 14 ancestors in all, the oldest K792558 (1979). 4 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK871202 Flashpak Container SystemPerformance Instruments Corp. · 1987
- 5 generations backK022978 Steritite Container with Flashtite Valve Plate (S) & Meditray ProductsCase Medical, Inc. · 2003
- 4 generations backK053389 Aesculap Sterilcontainer SystemAesculap, Inc. · 2006
- 3 generations backK073168 Aesculap Primeline Container LTD.Aesculap, Inc. · 2008
- 2 generations backK112671 Sterilcontainer SystemAesculap, Ltd. · 2012
- 1 generation backK192056 JJ Series Container SystemAesculap, Inc. · 2020
- This deviceK214041 Aesculap AICON ContainerAesculap, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK242762 Aesculap Aicon® Series Container SystemAesculap, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK250029 ONE TRAY® Sealed Sterilization Container SystemInnovative Sterilization Technologies · 2025
- Descendant · cites it directly · 0 of its ownK242834 System 9 Sterile Battery ContainerStryker Instruments · 2025
- Descendant · cites it directly · 0 of its ownK233578 Bahadir Sterilization ContainersBahadir USA, LLC · 2024
Most influential descendants
Showing 4 of 4 · See all- K242762Aesculap Aicon® Series Container SystemAesculap, Inc. · 2025 · cites it directly0descendants
- K250029ONE TRAY® Sealed Sterilization Container SystemInnovative Sterilization Technologies · 2025 · cites it directly0descendants
- K242834System 9 Sterile Battery ContainerStryker Instruments · 2025 · cites it directly0descendants
- K233578Bahadir Sterilization ContainersBahadir USA, LLC · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K871202 | Flashpak Container System | Performance Instruments Corp. | 1987 | — |
| −5 | K022978 | Steritite Container with Flashtite Valve Plate (S) & Meditray Products | Case Medical, Inc. | 2003 | — |
| −4 | K053389 | Aesculap Sterilcontainer System | Aesculap, Inc. | 2006 | — |
| −3 | K073168 | Aesculap Primeline Container LTD. | Aesculap, Inc. | 2008 | — |
| −2 | K112671 | Sterilcontainer System | Aesculap, Ltd. | 2012 | — |
| −1 | K192056 | JJ Series Container System | Aesculap, Inc. | 2020 | — |
| 0 (this device) | K214041 | Aesculap AICON Container | Aesculap, Inc. | 2022 | — |
| +1 | K242762 | Aesculap Aicon® Series Container System | Aesculap, Inc. | 2025 | — |
| +1 | K250029 | ONE TRAY® Sealed Sterilization Container System | Innovative Sterilization Technologies | 2025 | — |
| +1 | K242834 | System 9 Sterile Battery Container | Stryker Instruments | 2025 | — |
| +1 | K233578 | Bahadir Sterilization Containers | Bahadir USA, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1985 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 3 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KCT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KCT device
- #1 K261935 Surgical and Prosthetic Traysscore 15.0 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K192056 | JJ Series Container SystemSummary page 12…II per 21 CFR 880.6850 PREDICATE DEVICE TRADE NAME: Aesculap JJ Series Container System 510(k) NUMBER: K192056 COMMON NAME: Sterilization Container Wrap CLASSIFICATION NAME: Wrap, Sterilizat… | 2020 |
| † | K193582 | SterilContainer S2 System | 2020 |
| † | K182414 | Aesculap® SterilContainer (TM) S2 System | 2019 |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 35 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K242762 (Aesculap, Inc., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KCT devicesKCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · KCT
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KCT
205in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KCT
17in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KCT
50in 2025
MAUDE reports naming product code KCT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 199 | 0 | 2 |
| 2008 | 6 | 182 | 0 | 8 |
| 2009 | 6 | 89 | 0 | 5 |
| 2010 | 12 | 202 | 1 | 3 |
| 2011 | 6 | 117 | 2 | 3 |
| 2012 | 10 | 236 | 0 | 2 |
| 2013 | 8 | 131 | 1 | 6 |
| 2014 | 11 | 169 | 1 | 5 |
| 2015 | 15 | 151 | 0 | 6 |
| 2016 | 12 | 182 | 3 | 16 |
| 2017 | 10 | 211 | 1 | 3 |
| 2018 | 15 | 192 | 0 | 22 |
| 2019 | 18 | 187 | 0 | 15 |
| 2020 | 14 | 134 | 0 | 66 |
| 2021 | 18 | 185 | 1 | 26 |
| 2022 | 11 | 137 | 17 | 8 |
| 2023 | 10 | 94 | 0 | 30 |
| 2024 | 8 | 106 | 0 | 18 |
| 2025 | 11 | 205 | 0 | 50 |
| 2026 | 9 | 122 | 0 | — |
What is it indicated for?
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…
Read the full statement (134 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K214041 · printed Nov 6, 2026
Cite this page
510(k) Report. “K214041: Aesculap AICON Container.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K214041
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026