510(k) · Cleared
ClearedVideo Extended Length Tray (Plastic - Radel), Video Tray Single Level (Plastic - Radel), Video Arthroscope Tray (Plastic
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conmed Corporation · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Mar 28, 2014 as substantially equivalent to K122818 (Olympus Keymed (Medical & Industrial Equipment) LT, 2013) after a 179-day review. Its family tree reaches back 7 generations to 1984.
- Decided
- Mar 28, 2014
- Review
- 179 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K844002 (1984). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 6 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 5 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 4 generations backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- 3 generations backK033222 Olympus Sterilization TraysOlympus Winter & Ibe GmbH · 2004
- 2 generations backK092682 Gyrus Acmi Flexible Endoscope Storage-Sterilization TraysGyrus Acmi, Inc. · 2009
- 1 generation backK122818 Olympus Maj-172 Instrument Tray for LTF VideoscopeOlympus Keymed (Medical & Industrial Equipment) LT · 2013
- This deviceK133116 Video Extended Length Tray (Plastic - Radel), Video Tray Single…Conmed Corporation · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −6 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −5 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −4 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| −3 | K033222 | Olympus Sterilization Trays | Olympus Winter & Ibe GmbH | 2004 | — |
| −2 | K092682 | Gyrus Acmi Flexible Endoscope Storage-Sterilization Trays | Gyrus Acmi, Inc. | 2009 | — |
| −1 | K122818 | Olympus Maj-172 Instrument Tray for LTF Videoscope | Olympus Keymed (Medical & Industrial Equipment) LT | 2013 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K122818 | Olympus Maj-172 Instrument Tray for LTF VideoscopeSummary page 1…icate Device: Olympus MAJ- 172 Instrument Tray for LTF Videoscope Company Name: KeyMed (Medical and Industrial Ltd) 5 10(k) Number: K122818 510(k) Summary K1331 16 1 of 11 rfCONMED CRP0 RAT ION 807.92… | 2013 |
| † | K033222 | Olympus Sterilization Trays | 2004 |
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 30 years and passes through 8 companies; a new generation was cleared every 3.1 years on median.
- None of the 12 ancestors has a recall.
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. 2014, 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 Video Trays listed above are used for loading surgical instruments in or to conveniently organize, sterilize, transport and store the instruments between uses. The Video Trays listed above are not intended to maintain sterility: they are intended to be used in conjunction with a validated FDA cleared sterilization wrap in order to maintain sterility of the enclosed medical instruments. The Video Trays listed above are intended to be used to enclose…
Read the full statement (353 words)
The Video Trays listed above are used for loading surgical instruments in or to conveniently organize, sterilize, transport and store the instruments between uses. The Video Trays listed above are not intended to maintain sterility: they are intended to be used in conjunction with a validated FDA cleared sterilization wrap in order to maintain sterility of the enclosed medical instruments.
The Video Trays listed above are intended to be used to enclose ConMed medical devices including hand instruments, trocars, camera heads, adapters, endoscopes, light guides, and bridge systems to steam sterilize the enclosed medical devices by a health care provider.
The instrument trays were validated as per below sterilization parameters:
Steam (wrapped) sterilization
Pre-vacuum cycle at 270 F ( 132 'C) for 4 minutes
Cool down to 480 C for 118 minutes
VP 1003 Video Extended Length Tray (RADEL) dry cycle is 35 minutes. ConMed Corporation instruments which can be sterilized in this tray are scopes with an outer diameter not less than 5.5mm or greater than 10mm with lengths no greater than 530mm, and light guides with a length no greater than 10ft
VP 1005 Video Tray Single Level (RADEL) dry cycle is 40 minutes. ConMed Corporation instruments which can be sterilized in this tray are Scopes, Sheaths, Cannulas and Bridge System with internal diameters not less than 2.3mm, outer diameter not less than 2.9mm or greater than 10mm, and with lengths no greater than 404mm. Non-Cannulated, Non-Porous instruments with outer diameters not less than 2.9mm or greater than 3.2mm and with lengths no greater than 404mm may also be sterilized in this tray.
VP 1006 Video Arthroscope Tray (RADEL) dry cycle is 20 minutes. ConMed Corporation instruments which can be sterilized in this tray are scopes with diameters not less than 2.9mm or greater than 4mm, with lengths no greater than 233mm.
VP 1007 Video Laparoscope Tray (RADEL) dry cycle is 25 minutes. ConMed Corporation instruments which can be sterilized in this tray are scopes with diameters not less than 5.5mm or greater than 10mm, with lengths no greater than 404mm.
For additional instrument trays specifications refer to the table below.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133116 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133116: Video Extended Length Tray (Plastic - Radel), Video Tray Single Level (Plastic - Radel), Video Arthroscope Tray (Plastic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133116
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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