510(k) · Cleared
ClearedAesculap Aicon® Series Container System
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 May 13, 2025 as substantially equivalent to K214041 (Aesculap, Inc., 2022) after a 243-day review. Its family tree reaches back 7 generations to 1987.
- Decided
- May 13, 2025
- Review
- 243 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K871202 (1987). 15 ancestors in all, the oldest K792558 (1979). No later device cites it as a predicate yet.
- Root · 7 generations backK871202 Flashpak Container SystemPerformance Instruments Corp. · 1987
- 6 generations backK022978 Steritite Container with Flashtite Valve Plate (S) & Meditray ProductsCase Medical, Inc. · 2003
- 5 generations backK053389 Aesculap Sterilcontainer SystemAesculap, Inc. · 2006
- 4 generations backK073168 Aesculap Primeline Container LTD.Aesculap, Inc. · 2008
- 3 generations backK112671 Sterilcontainer SystemAesculap, Ltd. · 2012
- 2 generations backK192056 JJ Series Container SystemAesculap, Inc. · 2020
- 1 generation backK214041 Aesculap AICON ContainerAesculap, Inc. · 2022
- This deviceK242762 Aesculap Aicon® Series Container SystemAesculap, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K871202 | Flashpak Container System | Performance Instruments Corp. | 1987 | — |
| −6 | K022978 | Steritite Container with Flashtite Valve Plate (S) & Meditray Products | Case Medical, Inc. | 2003 | — |
| −5 | K053389 | Aesculap Sterilcontainer System | Aesculap, Inc. | 2006 | — |
| −4 | K073168 | Aesculap Primeline Container LTD. | Aesculap, Inc. | 2008 | — |
| −3 | K112671 | Sterilcontainer System | Aesculap, Ltd. | 2012 | — |
| −2 | K192056 | JJ Series Container System | Aesculap, Inc. | 2020 | — |
| −1 | K214041 | Aesculap AICON Container | Aesculap, Inc. | 2022 | — |
| 0 (this device) | K242762 | Aesculap Aicon® Series Container System | Aesculap, Inc. | 2025 | — |
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 |
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 K214041 Aesculap AICON Containerscore 18.1 · 6 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 |
|---|---|---|---|
| * | K214041 | Aesculap AICON ContainerSummary page 17…CE CLASS: Class II per 21 CFR 880.6850 PREDICATE DEVICE • Primary predicate: Aicon® JJ Series Container for low temperature sterilization (K214041). • Reference Device: Aicon® JJ Series Container for PreVac Steam sterilization (K192056) DEVICE DESCRIPTION The AESCULAP Ai… | 2022 |
| † | K192056 | JJ Series Container System | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 38 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 15 ancestors has a recall of any class.
- 3 other devices also cite its predicate K214041.
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. 2025, 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 (386 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
• 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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242762 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242762: Aesculap Aicon® Series Container System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242762
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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