510(k) · Cleared
ClearedSterilcontainer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Ltd. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on May 4, 2012 as substantially equivalent to K073168 (Aesculap, Inc., 2008) and 3 other predicates after a 233-day review. Its family tree reaches back 4 generations to 1987. 7 later devices descend from it.
- Decided
- May 4, 2012
- Review
- 233 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K871202 (1987). 12 ancestors in all, the oldest K792558 (1979). 7 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK871202 Flashpak Container SystemPerformance Instruments Corp. · 1987
- 3 generations backK022978 Steritite Container with Flashtite Valve Plate (S) & Meditray ProductsCase Medical, Inc. · 2003
- 2 generations backK053389 Aesculap Sterilcontainer SystemAesculap, Inc. · 2006
- 1 generation backK073168 Aesculap Primeline Container LTD.Aesculap, Inc. · 2008
- This deviceK112671 Sterilcontainer SystemAesculap, Ltd. · 2012
- Descendant · cites it directly · 5 of its ownK192056 JJ Series Container SystemAesculap, Inc. · 2020
- Descendant · 2 generations on · 4 of its ownK214041 Aesculap AICON ContainerAesculap, Inc. · 2022
- Descendant · 3 generations on · 0 of its ownK242762 Aesculap Aicon® Series Container SystemAesculap, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK250029 ONE TRAY® Sealed Sterilization Container SystemInnovative Sterilization Technologies · 2025
- Descendant · 3 generations on · 0 of its ownK242834 System 9 Sterile Battery ContainerStryker Instruments · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K192056JJ Series Container SystemAesculap, Inc. · 2020 · cites it directly5descendants
- K214041Aesculap AICON ContainerAesculap, Inc. · 2022 · 2 generations on4descendants
- K242762Aesculap Aicon® Series Container SystemAesculap, Inc. · 2025 · 3 generations on0descendants
- K250029ONE TRAY® Sealed Sterilization Container SystemInnovative Sterilization Technologies · 2025 · 3 generations on0descendants
- K242834System 9 Sterile Battery ContainerStryker Instruments · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K871202 | Flashpak Container System | Performance Instruments Corp. | 1987 | — |
| −3 | K022978 | Steritite Container with Flashtite Valve Plate (S) & Meditray Products | Case Medical, Inc. | 2003 | — |
| −2 | K053389 | Aesculap Sterilcontainer System | Aesculap, Inc. | 2006 | — |
| −1 | K073168 | Aesculap Primeline Container LTD. | Aesculap, Inc. | 2008 | — |
| 0 (this device) | K112671 | Sterilcontainer System | Aesculap, Ltd. | 2012 | — |
| +1 | K192056 | JJ Series Container System | Aesculap, Inc. | 2020 | — |
| +2 | K214041 | Aesculap AICON Container | Aesculap, Inc. | 2022 | — |
| +3 | K242762 | Aesculap Aicon® Series Container System | Aesculap, Inc. | 2025 | — |
| +3 | K250029 | ONE TRAY® Sealed Sterilization Container System | Innovative Sterilization Technologies | 2025 | — |
| +3 | K242834 | System 9 Sterile Battery Container | Stryker Instruments | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 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 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? (4)
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 |
|---|---|---|---|
| * | K073168 | Aesculap Primeline Container LTD.Summary page 1…KCT SUBSTANTIAL EQUIVALENCE Aesculap, Inc. believes that the SterilContainer is substantially equivalent to: * Aesculap PrimeLine Container (K073168) * Aesculap SterilContainer System (Flash Indication) (K(053389) * Aesculap PriMed Rigid Container System (K(944864)… | 2008 |
| * | K053389 | Aesculap Sterilcontainer SystemSummary page 3…anufacture the predicate devices. The new three-quarter size eight inch (187mm) container is exactly the same as the SterilContainers that received clearance in K944864, K053389, and K073168 with the exception of its size. This container represents the worst case vent to volume ratio for the SterilContairi… | 2006 |
| * | K944864 | Primed Rigid Container SystemSummary page 3…used to manufacture the predicate devices. The new three-quarter size eight inch (187mm) container is exactly the same as the SterilContainers that received clearance in K944864, K053389, and K073168 with the exception of its size. This container represents the worst case vent to volume ratio for the Steri… | 1994 |
| * | K792558 | Container SystemSummary page 1…073168) * Aesculap SterilContainer System (Flash Indication) (K(053389) * Aesculap PriMed Rigid Container System (K(944864) * Aesculap Container System (K(792558) DEVICE DESCRIPTION The Aesculap SterilContainer is designed as a container system that will allow for sterilization and stor… | 1979 |
What descends from it? (7)
2 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 25 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K192056 (Aesculap, Inc., 2020) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K073168.
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. 2012, 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 System is a reusable 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 for 360 days. The SterilContainer System includes accessories such as mats, baskets, trays, holders, organizers, filters, indicator cards and tamper proof locks. The container system…
Read the full statement (163 words)
The Aesculap SterilContainer System is a reusable 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 for 360 days. The SterilContainer System includes accessories such as mats, baskets, trays, holders, organizers, filters, indicator cards and tamper proof locks.
The container system consists of a three-quarter size, 8" tall perforated (JN744) or solid (JK744) aluminum bottom and a three-quarter size aluminum or PrimeL-ine lid. The lids are available in different colors to aide in set recognition. There are three types of filter materials. A single use paper filter (US751, US9S4), a single use polypropylene filter (MD344), and a reusable PTIFE filter (JKO9O). The reusable PTFE is validated for 2200 uses. There are a variety of accessories for use with the container system. Please refer to the chart on the next page for sterilization compatibility of the container system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112671 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112671: Sterilcontainer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112671
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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