510(k) · Cleared
ClearedOlympus Instrument Tray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Winter & Ibe GmbH · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Feb 15, 2012 as substantially equivalent to K092682 (Gyrus Acmi, Inc., 2009) and 1 other predicate after a 335-day review. Its family tree reaches back 6 generations to 1984.
- Decided
- Feb 15, 2012
- Review
- 335 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K844002 (1984). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 5 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 4 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 3 generations backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- 2 generations backK033222 Olympus Sterilization TraysOlympus Winter & Ibe GmbH · 2004
- 1 generation backK092682 Gyrus Acmi Flexible Endoscope Storage-Sterilization TraysGyrus Acmi, Inc. · 2009
- This deviceK110748 Olympus Instrument TrayOlympus Winter & Ibe GmbH · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −5 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −4 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −3 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| −2 | K033222 | Olympus Sterilization Trays | Olympus Winter & Ibe GmbH | 2004 | — |
| −1 | K092682 | Gyrus Acmi Flexible Endoscope Storage-Sterilization Trays | Gyrus Acmi, Inc. | 2009 | — |
| 0 (this device) | K110748 | Olympus Instrument Tray | Olympus Winter & Ibe GmbH | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 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? (2)
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 |
|---|---|---|---|
| * | K092682 | Gyrus Acmi Flexible Endoscope Storage-Sterilization TraysSummary page 1…t Code: KCT * Classification Panel: General Hospital * Performance Standards: None established * Predicate Devices: * K092682 Gyrus ACMI® Flexible Endoscope Storage- Sterilization Trays… | 2009 |
| * | K033222 | Olympus Sterilization TraysSummary page 1…ices: * K092682 Gyrus ACMI® Flexible Endoscope Storage- Sterilization Trays . K033222 Olympus Sterilization Trays * Intended Use: This instrument tray is intended to be used to enclose and protect Olympus flexible… | 2004 |
| † | K082554 | Kimguard Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC500 and KC600 | 2009 |
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 28 years and passes through 6 companies; a new generation was cleared every 3.1 years on median.
- None of the 11 ancestors has a recall.
- 3 other devices also cite its predicate K092682.
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?
This instrument tray is intended to be used to enclose and protect Olympus flexible endoscopes during sterilization. The instrument tray is designed to hold one endoscope at a time and is to be used in conjunction with an FDA cleared sterilization wrap for ethylene oxide sterilization.
the instrument tray is an optional accessory to the Olympus endoscopes for which it is designed. Maintenance of sterility depends on the sterilization wrap, not on the instrument tray.
This instrument tray is indicated for ethylene oxide sterilization of only compatible Olympus endoscopes. For compatible endoscopes, refer to the table below, "Compatible Olympus Endoscopes".
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110748 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110748: Olympus Instrument Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110748
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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