510(k) · Cleared
ClearedSterilContainer S2 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 Mar 17, 2020 as substantially equivalent to K182414 (Aesculap, Inc., 2019) and 2 other predicates after an 85-day review. Its family tree reaches back 5 generations to 1987.
- Decided
- Mar 17, 2020
- Review
- 85 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K871202 (1987). 18 ancestors in all, the oldest K792558 (1979). No later device cites it as a predicate yet.
- Root · 5 generations backK871202 Flashpak Container SystemPerformance Instruments Corp. · 1987
- 4 generations backK022978 Steritite Container with Flashtite Valve Plate (S) & Meditray ProductsCase Medical, Inc. · 2003
- 3 generations backK053389 Aesculap Sterilcontainer SystemAesculap, Inc. · 2006
- 2 generations backK073168 Aesculap Primeline Container LTD.Aesculap, Inc. · 2008
- 1 generation backK112671 Sterilcontainer SystemAesculap, Ltd. · 2012
- This deviceK193582 SterilContainer S2 SystemAesculap, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K871202 | Flashpak Container System | Performance Instruments Corp. | 1987 | — |
| −4 | K022978 | Steritite Container with Flashtite Valve Plate (S) & Meditray Products | Case Medical, Inc. | 2003 | — |
| −3 | K053389 | Aesculap Sterilcontainer System | Aesculap, Inc. | 2006 | — |
| −2 | K073168 | Aesculap Primeline Container LTD. | Aesculap, Inc. | 2008 | — |
| −1 | K112671 | Sterilcontainer System | Aesculap, Ltd. | 2012 | — |
| 0 (this device) | K193582 | SterilContainer S2 System | Aesculap, Inc. | 2020 | — |
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 | 2 | 0 |
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 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? (3)
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 |
|---|---|---|---|
| * | K182414 | Aesculap® SterilContainer (TM) S2 SystemSummary page 6…ODE: KCT DEVICE CLASS: Class II per 21 CFR 880.6850 PREDICATE DEVICES Aesculap SterilContainer S2 System - K182414 (Primary), SterilContainer S System - K162815 SterilContainer System - K112671 DEVICE DESCRIPTION The Aesculap SterilContainer… | 2019 |
| * | K162815 | SterilContainer S SystemSummary page 6…CLASS: Class II per 21 CFR 880.6850 PREDICATE DEVICES Aesculap SterilContainer S2 System - K182414 (Primary), SterilContainer S System - K162815 SterilContainer System - K112671 DEVICE DESCRIPTION The Aesculap SterilContainer S2 System is a reusable rigid container syste… | 2017 |
| * | K112671 | Sterilcontainer SystemSummary page 6…Class II per 21 CFR 880.6850 PREDICATE DEVICES Aesculap SterilContainer S2 System - K182414 (Primary), SterilContainer S System - K162815 SterilContainer System - K112671 DEVICE DESCRIPTION The Aesculap SterilContainer S2 System is a reusable rigid container system intended for sterilization and… | 2012 |
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 33 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 18 ancestors has a recall of any class.
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. 2020, 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 SterilContainer™ S2 System is a reusable rigid sterilization container system 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 until used. This container system is compatible for use in the following sterilization modalities: • Ethylene Oxide • STERRAD 100NX DUO cycle •…
Read the full statement (111 words)
The Aesculap SterilContainer™ S2 System is a reusable rigid sterilization container system 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 until used. This container system is compatible for use in the following sterilization modalities:
• Ethylene Oxide
• STERRAD 100NX DUO cycle
• STERIZONE VP4
The Aesculap SterilContainer S2 System includes accessories such as silicone mats and organizers, stainless steel baskets, trays, holders, sterilization indicator cards and tamper proof locks.
The attached table identifies the validated load configurations for each of the modalities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193582 · printed Nov 5, 2026
Cite this page
510(k) Report. “K193582: SterilContainer S2 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K193582
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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