510(k) · Cleared
ClearedSonicision Sterilization Tray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Apr 19, 2012 as substantially equivalent to K090818 (KARL STORZ Endoscopy-America, Inc., 2009) after a 231-day review. Its family tree reaches back 1 generation to 2009. 2 later devices descend from it.
- Decided
- Apr 19, 2012
- Review
- 231 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K090818 (2009). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK090818 Karl Storz -Endoscope Sterilization Trays, Models 39402AS…KARL STORZ Endoscopy-America, Inc. · 2009
- This deviceK112536 Sonicision Sterilization TrayCovidien · 2012
- Descendant · cites it directly · 1 of its ownK131170 Sonicision Sterilization TrayCovidien, Formerly Valleylab, A Division of Tyco H · 2013
- Descendant · 2 generations on · 0 of its ownK151347 MIS Spine Frame Instrument CaseThompson Surgical Instruments · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K090818 | Karl Storz -Endoscope Sterilization Trays, Models 39402AS, 39301HCTS, 39301BS | KARL STORZ Endoscopy-America, Inc. | 2009 | — |
| 0 (this device) | K112536 | Sonicision Sterilization Tray | Covidien | 2012 | — |
| +1 | K131170 | Sonicision Sterilization Tray | Covidien, Formerly Valleylab, A Division of Tyco H | 2013 | — |
| +2 | K151347 | MIS Spine Frame Instrument Case | Thompson Surgical Instruments | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K090818 | Karl Storz -Endoscope Sterilization Trays, Models 39402AS, 39301HCTS, 39301BSSummary page 1…o be substantially equivalent to the following sterilization tray in commercial distribution: Device Name: Sterilization Tray Model Number: 39301 BCTS 5 10(k) Number: K(090818 (cleared 8/18/2 009) Manufacturer: Karl Storz Endoscopy-America, Inc. Device Description The SonicisionTm Sterilization Tray (SC… | 2009 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131170 | Sonicision Sterilization Tray | 2013 | 1 |
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?
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 Sonicision Sterilization Tray (SCST) is intended to be used to encase and protect reusable battery packs (SCB) and generators (SCG) of the Sonicision system during sterilization and storage. The tray containing up to one generator and one battery pack (Maximum Load) can be used with the STERRADO 100S model and pre-set (non-adjustable) Standard cycle. The tray within its sterile barrier is intended to maintain sterility for up to 30 days.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112536 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112536: Sonicision Sterilization Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112536
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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