510(k) · Cleared
ClearedOlympus Maj-172 Instrument Tray for LTF Videoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Keymed (Medical & Industrial Equipment) LT · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Jan 4, 2013 as substantially equivalent to K033222 (Olympus Winter & Ibe GmbH, 2004) and 1 other predicate after a 112-day review. Its family tree reaches back 6 generations to 1984. 1 later device descends from it.
- Decided
- Jan 4, 2013
- Review
- 112 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. 1 later device descends from it, 1 citing it directly.
- 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 deviceK122818 Olympus Maj-172 Instrument Tray for LTF VideoscopeOlympus Keymed (Medical & Industrial Equipment) LT · 2013
- Descendant · cites it directly · 0 of its ownK133116 Video Extended Length Tray (Plastic - Radel), Video Tray Single…Conmed Corporation · 2014
Most influential descendants
Showing 1 of 1 · See all- K133116Video Extended Length Tray (Plastic - Radel), Video Tray Single Level (Plastic - Radel)…Conmed Corporation · 2014 · cites it directly0descendants
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) | K122818 | Olympus Maj-172 Instrument Tray for LTF Videoscope | Olympus Keymed (Medical & Industrial Equipment) LT | 2013 | — |
| +1 | K133116 | Video Extended Length Tray (Plastic - Radel), Video Tray Single Level (Plastic… | Conmed Corporation | 2014 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 |
|---|---|---|---|
| * | K033222 | Olympus Sterilization TraysSummary page 1…ication Name: Sterilization wrap, containers, trays, cassettes and other accessories 4. PREDICATE DEVICES * Olympus Sterilization Trays (K033222) * Gymus ACMI Flexible Endoscope Storage-Sterilization Tray (K092682) KeyMed (Industrial & Medical) Ltd October… | 2004 |
| * | K092682 | Gyrus Acmi Flexible Endoscope Storage-Sterilization TraysSummary page 1…accessories 4. PREDICATE DEVICES * Olympus Sterilization Trays (K033222) * Gymus ACMI Flexible Endoscope Storage-Sterilization Tray (K092682) KeyMed (Industrial & Medical) Ltd October 16, 2Q12 2~ Supplement I… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133116 | Video Extended Length Tray (Plastic - Radel), Video Tray Single Level (Plastic - Radel)… | 2014 | 0 |
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 29 years and passes through 7 companies; a new generation was cleared every 3.1 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K133116 (Conmed Corporation, 2014) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K033222.
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. 2013, 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 Olympus MAJ-172 Instrument Tray for LTF Videoscope is 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 or ethylene oxide sterilization of the enclosed medical device. The Olympus MAJ-172 Instrument Tray for LTF Videoscope is a purpose designed transport and sterilization case indicated for use in…
Read the full statement (224 words)
The Olympus MAJ-172 Instrument Tray for LTF Videoscope is 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 or ethylene oxide sterilization of the enclosed medical device. The Olympus MAJ-172 Instrument Tray for LTF Videoscope is a purpose designed transport and sterilization case indicated for use in medical facilities to accommodate an endoscope from the Olympus LTF range of videoscopes, plus certain identified accessories, for reprocessing by autoclaving (steam) or ETO sterilization (depending on the model). LTF Type 160 and VH videoscopes are compatible with Steam and ETO sterilization cycles. LTF Type V3 and VP are compatible only with ETO sterilization cycles.
The Olympus MAJ-172 Instrument Tray for LTF Videoscope is designed to secure and store a single videoscope and Its accessoriesfor sterilization at a healthcare facility. Refer to the instrument tray instructions for use for the proper orientation of the videoscope and accessories within the instrument tray. The recommended sterilization cycles for the LTF videoscopes are as follows'
ETO Sterilization... Steam Sterilization:
100% ETO concentration: 735 mgIL Vacuum: 0.016 MPa minimum
Temp: 57 0C *.Pressure: 0.101 MPa minimum
Relative Humidity: 70% Temp: 135 C
Processing (Hold) lime: 1 hour Exposure lime: 3 minutes
Aeration ime: 12-hours Drying lime: 20 minutes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122818 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122818: Olympus Maj-172 Instrument Tray for LTF Videoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122818
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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