510(k) · Cleared
ClearedJJ 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 Mar 27, 2020 as substantially equivalent to K112671 (Aesculap, Ltd., 2012) after a 239-day review. Its family tree reaches back 5 generations to 1987. 5 later devices descend from it.
- Decided
- Mar 27, 2020
- Review
- 239 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K871202 (1987). 13 ancestors in all, the oldest K792558 (1979). 5 later devices descend from it, 1 citing it directly.
- 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 deviceK192056 JJ Series Container SystemAesculap, Inc. · 2020
- Descendant · cites it directly · 4 of its ownK214041 Aesculap AICON ContainerAesculap, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK242762 Aesculap Aicon® Series Container SystemAesculap, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK250029 ONE TRAY® Sealed Sterilization Container SystemInnovative Sterilization Technologies · 2025
- Descendant · 2 generations on · 0 of its ownK242834 System 9 Sterile Battery ContainerStryker Instruments · 2025
- Descendant · 2 generations on · 0 of its ownK233578 Bahadir Sterilization ContainersBahadir USA, LLC · 2024
Most influential descendants
Showing 5 of 5 · See all- K214041Aesculap AICON ContainerAesculap, Inc. · 2022 · cites it directly4descendants
- K242762Aesculap Aicon® Series Container SystemAesculap, Inc. · 2025 · 2 generations on0descendants
- K250029ONE TRAY® Sealed Sterilization Container SystemInnovative Sterilization Technologies · 2025 · 2 generations on0descendants
- K242834System 9 Sterile Battery ContainerStryker Instruments · 2025 · 2 generations on0descendants
- K233578Bahadir Sterilization ContainersBahadir USA, LLC · 2024 · 2 generations on0descendants
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) | K192056 | JJ Series Container System | Aesculap, Inc. | 2020 | — |
| +1 | K214041 | Aesculap AICON Container | Aesculap, Inc. | 2022 | — |
| +2 | K242762 | Aesculap Aicon® Series Container System | Aesculap, Inc. | 2025 | — |
| +2 | K250029 | ONE TRAY® Sealed Sterilization Container System | Innovative Sterilization Technologies | 2025 | — |
| +2 | K242834 | System 9 Sterile Battery Container | Stryker Instruments | 2025 | — |
| +2 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K112671 | Sterilcontainer SystemSummary page 12…Aesculap JJ Series Container System Aesculap SterilContainer ( K192056) (K112671) Product Code: KCT Product Code: KCT Intended Use A device intended to b… | 2012 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K214041 | Aesculap AICON Container | 2022 | 4 |
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 13 ancestors has a recall of any class.
- Of its descendants, K214041 (Aesculap, Inc., 2022) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K112671.
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 JJ Series Container 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 during transport and until used. This container system is compatible for use in steam sterilization according to the configurations listed in the…
Read the full statement (556 words)
The Aesculap JJ Series Container 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 during transport and until used. This container system is compatible for use in steam sterilization according to the configurations listed in the tables below.
The JJ Series Container System consists of two different container styles: a solid bottom container and enhanced drying system (EDS) container.
The Aesculap JJ Series Container System includes accessories such as baskets, trays, silicone mats, instrument organizational accessories, holders, indicator cards, tamper evident locks, lid covers, faceplate holders, and tags.
The attached tables identifies the load configurations.
Table 1. JJ Series Container System Lumen Configurations
Sterilization Cycle | Size | Lumens
PreVac Steam with dry time (270°F 4 min Exposure) | Full Size | 4 stainless steel lumens with > 1mm ID x <500mm L
PreVac Steam with dry time (270°F 4 min Exposure) | Three-Quarter Size | 4 stainless steel lumens with > 1mm ID x <400mm L
PreVac Steam with dry time (270°F 4 min Exposure) | Half Size | 4 stainless steel lumens with > 1mm ID x <200mm L
Prevac Steam without dry time (270°F 3 min Exposure) Non-Porous | Full Size | Non lumened instruments
Prevac Steam without dry time (270°F 3 min Exposure) Non-Porous | Three-Quarter Size | Non lumened instruments
Prevac Steam without dry time (270°F 3 min Exposure) Non-Porous | Half Size | Non lumened instruments
Prevac Steam without dry time (270°F 4 min Exposure) Porous | Full Size | 4 stainless steel lumens with > 1mm ID x <500mm L
Prevac Steam without dry time (270°F 4 min Exposure) Porous | Three-Quarter Size | 4 stainless steel lumens with > 1mm ID x <400mm L
Prevac Steam without dry time (270°F 4 min Exposure) Porous | Half Size | 4 stainless steel lumens with > 1mm ID x <125mm L
Validation testing was performed using the JJ612 single use paper filter.
Table 2. JJ Series Container System Configurations, Without Silicone Mat and Lid cover*
[Configurations of solid bottom and EDS containers for Prevac Steam cycles, including the listed container bottom and lid part numbers, maximum load weights, and specified exposure and dry times.]
Table 3. JJ Series Container System Configurations, with Silicone Mat and Lid Cover*
[Configurations of solid bottom and EDS containers for Prevac Steam cycles, including the listed container bottom and lid part numbers, maximum load weights, and specified exposure and dry times.]
*Dry times and load weights are based on container with silicone mats and/or lid cover.
Table 4: Sterilization Cycle Compatible Accessories - Prevac Steam
Accessories | Prevac Steam with dry time | Prevac Steam Without dry time
Baskets, trays, indicator cards, tamper evident locks, faceplate holders, and tags. | Yes | Yes
Instrument Organization System (Silicone and Stainless Steel racks, brackets, holders, and clamps) | Yes | Yes
Silicone mats | Yes1 | Yes
Lid Covers | Yes1 | Yes
1 Using silicone mats and/or lid covers may require a longer drying time.
When used with PreVac Steam with dry time (270°F, 4 minute exposure), the maintenance of sterility of the Aesculap JJ Series Container System is 365 days.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192056 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192056: JJ 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/K192056
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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