510(k) · Cleared
ClearedGyrus Acmi Telescope Storage-Sterilization Tray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gyrus Acmi, Inc. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Jul 10, 2012 as substantially equivalent to K092682 (Gyrus Acmi, Inc., 2009) after a 145-day review. Its family tree reaches back 6 generations to 1984.
- Decided
- Jul 10, 2012
- Review
- 145 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
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 deviceK120474 Gyrus Acmi Telescope Storage-Sterilization TrayGyrus Acmi, Inc. · 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) | K120474 | Gyrus Acmi Telescope Storage-Sterilization Tray | Gyrus Acmi, Inc. | 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? (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 |
|---|---|---|---|
| * | K092682 | Gyrus Acmi Flexible Endoscope Storage-Sterilization TraysSummary page 1…wrap containers, trays, cassettes & other accessories Predicate Device K092682 Intended Use The Gymus ACMI Telescope Storage-Sterilization Tray (TEL-GT) is intended to be used to enclose and pr… | 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?
The Gymus AGMI Telescope Storage-Sterilization Tray (TEL-GT) is intended to be used to enclose and protect Gyrus ACKII telescopes during Steam Sterilization using the following parameters: STEAM Sterilization Parameters: PreVacuum Temp: 275 0 F 132 0 C Pressure 26psigs; Exposure 3 minutes Dry Time 20 minutes The trays are to be double wrapped with an FDA cleared sterilization wrap. The trays are optional accessories to the Gymos AGMI telescopes.…
Read the full statement (137 words)
The Gymus AGMI Telescope Storage-Sterilization Tray (TEL-GT) is intended to be used to enclose and protect Gyrus ACKII telescopes during Steam Sterilization using the following parameters:
STEAM Sterilization Parameters:
PreVacuum
Temp: 275 0 F
132 0 C
Pressure 26psigs;
Exposure 3 minutes
Dry Time 20 minutes
The trays are to be double wrapped with an FDA cleared sterilization wrap. The trays are optional accessories to the Gymos AGMI telescopes. Telescopes without lumens up to 31 cm in length may be sterilized in the tray with a diameter between 2.7mm to 4mm. Two telescopes can be sterilized at one time.
Maintenance of Sterility is dependent on the sterilization wrap shelf life and not the tray. User must follow the instructions for use supplied with the sterilization wrap and follow manufacturers recommended storage conditions and timeframes for shelf life.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120474 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120474: Gyrus Acmi Telescope Storage-Sterilization Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120474
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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