510(k) · Cleared
ClearedSteriCUBE® Multiple Tray Sterilization Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stericube, LLC · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Sep 28, 2022 as substantially equivalent to K190541 (Pmbs, LLC, 2019) after a 57-day review. Its family tree reaches back 3 generations to 2012.
- Decided
- Sep 28, 2022
- Review
- 57 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K110898 (2012). No later device cites it as a predicate yet.
- Root · 3 generations backK110898 S.C.O.R.E.S. UnitAmmed Surgical Equipment, LLC · 2012 · Recalled
- 2 generations backK152014 MTS300 Multiple Tray Sterilization SystemPmbs, LLC · 2015
- 1 generation backK190541 MTS225 and MTS300 Multiple Tray Sterilization SystemsPmbs, LLC · 2019
- This deviceK222328 SteriCUBE® Multiple Tray Sterilization SystemsStericube, LLC · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K110898 | S.C.O.R.E.S. Unit | Ammed Surgical Equipment, LLC | 2012 | 1 |
| −2 | K152014 | MTS300 Multiple Tray Sterilization System | Pmbs, LLC | 2015 | — |
| −1 | K190541 | MTS225 and MTS300 Multiple Tray Sterilization Systems | Pmbs, LLC | 2019 | — |
| 0 (this device) | K222328 | SteriCUBE® Multiple Tray Sterilization Systems | Stericube, LLC | 2022 | — |
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 |
|---|---|---|---|
| * | K190541 | MTS225 and MTS300 Multiple Tray Sterilization SystemsSummary page 4…ray Sterilization Systems Predicate MTS225 and MTS300 Multiple Tray Sterilization Systems (“MTS Systems”) Device cleared most recently November 5, 2019, via K190541 Device The SteriCUBE® Multiple Tray Sterilization Systems are also referred to as Description the “SteriCUBE Systems”… | 2019 |
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 10 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 3 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. 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 SteriCUBE Multiple Tray Sterilization System (SteriCUBE System) is indicated for enclosing other medical devices that are to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed materials and maintain sterility for up to 30 days until used. The unit must be used with the SteriCUBE System Transfer Cart, SteriCUBE System Filters and SteriCUBE System Integrity Locks. The SteriCUBE System is intended to be used in…
Read the full statement (191 words)
The SteriCUBE Multiple Tray Sterilization System (SteriCUBE System) is indicated for enclosing other medical devices that are to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed materials and maintain sterility for up to 30 days until used. The unit must be used with the SteriCUBE System Transfer Cart, SteriCUBE System Filters and SteriCUBE System Integrity Locks.
The SteriCUBE System is intended to be used in prevacuum steam sterilizers with a prevacuum cycle of 270°F and exposure time of 4 minutes. Use no more than 3 trays per shelf or 25 Ibs. per tray.
The SteriCUBE System was tested and validated with rigid instruments containing lumens with an inner diameter of 0.7mm and an overall length of 500mm as well as lumens with an inner diameter of 1.0mm and an overall length of 850mm. Do not use with instruments containing lumens with an inner diameter smaller than 0.7mm and an overall length longer than 500mm or lumens with an inner diameter smaller than 1.0mm and an overall length longer than 850mm.
Use only uncovered, perforated or wire mesh general delivery trays within the SteriCUBE System.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K222328 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222328: SteriCUBE® Multiple Tray Sterilization Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222328
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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