510(k) · Cleared
ClearedOlympus Sterilization Trays
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 Aug 2, 2004 as substantially equivalent to K012105 (Symmetry Medical, Inc., 2002) after a 304-day review. Its family tree reaches back 4 generations to 1984. 1 of the 65 devices in its family, counting itself, has a Class I recall. 58 later devices descend from it.
- Decided
- Aug 2, 2004
- Review
- 304 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K844002 (1984). 6 ancestors in all. 58 later devices descend from it, 8 citing it directly. 1 of the 65 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 3 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 2 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 1 generation backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- This deviceK033222 Olympus Sterilization TraysOlympus Winter & Ibe GmbH · 2004
- Descendant · cites it directly · 29 of its ownK152241 Medtronic Transportation/Sterilization CassettesMedtronic Sofamor Danek USA, Inc. · 2016
- Descendant · 2 generations on · 18 of its ownK163600 Kit Boxes and Kit PlatesNobel Biocare AB · 2018
- Descendant · 3 generations on · 11 of its ownK180791 Straumann BLX Surgical CassetteInstitut Straumann AG · 2018
- Descendant · cites it directly · 10 of its ownK070769 VHP 136 TraySTERIS Corporation · 2007
- Descendant · 2 generations on · 7 of its ownK140494 V-Pro Sterilization Tray/ Sterilization MatSTERIS Corporation · 2014
Showing 5 of 58 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K050220 Evis Exera Bronchovideoscope, Olympus…cites it directly · 2005
Most influential descendants
Showing 5 of 58 · See all- K152241Medtronic Transportation/Sterilization CassettesMedtronic Sofamor Danek USA, Inc. · 2016 · cites it directly29descendants
- K163600Kit Boxes and Kit PlatesNobel Biocare AB · 2018 · 2 generations on18descendants
- K180791Straumann BLX Surgical CassetteInstitut Straumann AG · 2018 · 3 generations on11descendants
- K070769VHP 136 TraySTERIS Corporation · 2007 · cites it directly10descendants
- K140494V-Pro Sterilization Tray/ Sterilization MatSTERIS Corporation · 2014 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −3 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −2 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −1 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| 0 (this device) | K033222 | Olympus Sterilization Trays | Olympus Winter & Ibe GmbH | 2004 | — |
| +1 | K152241 | Medtronic Transportation/Sterilization Cassettes | Medtronic Sofamor Danek USA, Inc. | 2016 | — |
| +2 | K163600 | Kit Boxes and Kit Plates | Nobel Biocare AB | 2018 | — |
| +3 | K180791 | Straumann BLX Surgical Cassette | Institut Straumann AG | 2018 | — |
| +1 | K070769 | VHP 136 Tray | STERIS Corporation | 2007 | — |
| +2 | K140494 | V-Pro Sterilization Tray/ Sterilization Mat | STERIS Corporation | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 1 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 6 | 0 |
| 2019 | 9 | 0 |
| 2020 | 4 | 0 |
| 2021 | 7 | 0 |
| 2022 | 3 | 0 |
| 2023 | 6 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K012105 | Polyvac Surgical Instrument Delivery System | 2002 |
What descends from it? (58)
See all 588 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152241 | Medtronic Transportation/Sterilization Cassettes | 2016 | 29 |
| K070769 | VHP 136 Tray | 2007 | 10 |
| K072211 | Intuitive Surgical Instrument and Accessories Sterilization Trays | 2008 | 7 |
| K092682 | Gyrus Acmi Flexible Endoscope Storage-Sterilization Trays | 2009 | 5 |
| K171692 | Instrument basket, for EndoEYE | 2018 | 1 |
| K122818 | Olympus Maj-172 Instrument Tray for LTF Videoscope | 2013 | 1 |
| K110748 | Olympus Instrument Tray | 2012 | 0 |
| K050220 | Evis Exera Bronchovideoscope, Olympus XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2AC Class I | 2005 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K050220Evis Exera Bronchovideoscope, Olympus XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2ACOlympus Medical Systems Corporation · 2005 · Cites it directly · ◆ in the 2005 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 20 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K152241 (Medtronic Sofamor Danek USA, Inc., 2016) has gone furthest, with 29 descendants of its own.
- 20 other devices also cite its predicate K012105.
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.
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 Olympus sterilization trays are intended to be used to enclose Olympus medical devices including hand instruments, trocars, camera heads, adapter, and endoscopes to be sterilized by a health care provider. It is intended to allow steam sterilization of the enclosed medical device.
The qualification for sterilizing endoscopic instruments were validated with a process challenge device (PCD) by a GLP approved laboratory. The PCD has a diameter of 2 mm and a length of 1500 mm.
The Olympus sterilization trays are to be sterilized in the following cycle:
Prevacuum Steam: 132°C- 134°C- 5 minutes minimum
Drying Time: 10 - 20 minutes as needed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033222 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033222: Olympus Sterilization Trays.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033222
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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