510(k) · Cleared
ClearedKarl Storz -Endoscope Sterilization Trays, Models 39402AS, 39301HCTS, 39301BS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Aug 18, 2009 after a 146-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Aug 18, 2009
- Review
- 146 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK090818 Karl Storz -Endoscope Sterilization Trays, Models 39402AS…KARL STORZ Endoscopy-America, Inc. · 2009
- Descendant · cites it directly · 2 of its ownK112536 Sonicision Sterilization TrayCovidien · 2012
- Descendant · 2 generations on · 1 of its ownK131170 Sonicision Sterilization TrayCovidien, Formerly Valleylab, A Division of Tyco H · 2013
- Descendant · cites it directly · 0 of its ownK201945 KARL STORZ UDEL Sterilization TraysKarl Storz Endoscopy America, Inc. · 2021 · Recalled
- Descendant · 3 generations on · 0 of its ownK151347 MIS Spine Frame Instrument CaseThompson Surgical Instruments · 2015
Most influential descendants
Showing 4 of 4 · See all- K112536Sonicision Sterilization TrayCovidien · 2012 · cites it directly2descendants
- K131170Sonicision Sterilization TrayCovidien, Formerly Valleylab, A Division of Tyco H · 2013 · 2 generations on1descendant
- K201945KARL STORZ UDEL Sterilization TraysKarl Storz Endoscopy America, Inc. · 2021 · cites it directly0descendants
- K151347MIS Spine Frame Instrument CaseThompson Surgical Instruments · 2015 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K090818 | Karl Storz -Endoscope Sterilization Trays, Models 39402AS, 39301HCTS, 39301BS | KARL STORZ Endoscopy-America, Inc. | 2009 | — |
| +1 | K112536 | Sonicision Sterilization Tray | Covidien | 2012 | — |
| +2 | K131170 | Sonicision Sterilization Tray | Covidien, Formerly Valleylab, A Division of Tyco H | 2013 | — |
| +1 | K201945 | KARL STORZ UDEL Sterilization Trays | Karl Storz Endoscopy America, Inc. | 2021 | 1 |
| +3 | K151347 | MIS Spine Frame Instrument Case | Thompson Surgical Instruments | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
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?
- Of its descendants, K112536 (Covidien, 2012) has gone furthest, with 2 descendants of its own.
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. 2009, 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 KARL STORZ-ENDOSKOPE Sterilization Trays are intended only for use to encase and protect specific KARL STORZ reusable medical devices for sterilization in STERRAD 100S and NX Sterilization Systems, as indicated. STERRAD Sterilization Systems are pre-set and the cycle parameters can not be adjusted.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K090818 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090818: Karl Storz -Endoscope Sterilization Trays, Models 39402AS, 39301HCTS, 39301BS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090818
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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