510(k) · Cleared
ClearedGyrus Acmi Flexible Endoscope Storage-Sterilization Trays
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 Dec 11, 2009 as substantially equivalent to K040223 (Symmetry Medical USA, Inc., 2004) and 1 other predicate after a 101-day review. Its family tree reaches back 5 generations to 1984. 5 later devices descend from it.
- Decided
- Dec 11, 2009
- Review
- 101 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K844002 (1984). 10 ancestors in all. 5 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 4 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 3 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 2 generations backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- 1 generation backK033222 Olympus Sterilization TraysOlympus Winter & Ibe GmbH · 2004
- This deviceK092682 Gyrus Acmi Flexible Endoscope Storage-Sterilization TraysGyrus Acmi, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK122818 Olympus Maj-172 Instrument Tray for LTF VideoscopeOlympus Keymed (Medical & Industrial Equipment) LT · 2013
- Descendant · 2 generations on · 0 of its ownK133116 Video Extended Length Tray (Plastic - Radel), Video Tray Single…Conmed Corporation · 2014
- Descendant · cites it directly · 0 of its ownK120474 Gyrus Acmi Telescope Storage-Sterilization TrayGyrus Acmi, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK110748 Olympus Instrument TrayOlympus Winter & Ibe GmbH · 2012
- Descendant · cites it directly · 0 of its ownK102970 Gyrus Acmi Cyber Wand-Sterilization Trays Model FGTGyrus Acmi, Inc. · 2011
Most influential descendants
Showing 5 of 5 · See all- K122818Olympus Maj-172 Instrument Tray for LTF VideoscopeOlympus Keymed (Medical & Industrial Equipment) LT · 2013 · cites it directly1descendant
- K133116Video Extended Length Tray (Plastic - Radel), Video Tray Single Level (Plastic - Radel)…Conmed Corporation · 2014 · 2 generations on0descendants
- K120474Gyrus Acmi Telescope Storage-Sterilization TrayGyrus Acmi, Inc. · 2012 · cites it directly0descendants
- K110748Olympus Instrument TrayOlympus Winter & Ibe GmbH · 2012 · cites it directly0descendants
- K102970Gyrus Acmi Cyber Wand-Sterilization Trays Model FGTGyrus Acmi, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −4 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −3 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −2 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| −1 | K033222 | Olympus Sterilization Trays | Olympus Winter & Ibe GmbH | 2004 | — |
| 0 (this device) | 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 | — |
| +2 | K133116 | Video Extended Length Tray (Plastic - Radel), Video Tray Single Level (Plastic… | Conmed Corporation | 2014 | — |
| +1 | K120474 | Gyrus Acmi Telescope Storage-Sterilization Tray | Gyrus Acmi, Inc. | 2012 | — |
| +1 | K110748 | Olympus Instrument Tray | Olympus Winter & Ibe GmbH | 2012 | — |
| +1 | K102970 | Gyrus Acmi Cyber Wand-Sterilization Trays Model FGT | Gyrus Acmi, Inc. | 2011 | — |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K040223 | Polyvac Instrument Delivery SystemSummary page 1…Tra~t Generic/Common Name: Endoscope and accessories Predicate Devices Symmetry Medical PolyVac Instrument Delivery System K040223 Olymnpus Sterilization Tray K033222 Intended Uses The Gymus ACMI® Flexible Endoscope Sto… | 2004 |
| * | K033222 | Olympus Sterilization TraysSummary page 1…ssories Predicate Devices Symmetry Medical PolyVac Instrument Delivery System K040223 Olymnpus Sterilization Tray K033222 Intended Uses The Gymus ACMI® Flexible Endoscope Storage-Sterilization Trays are intended to be used to enclose and protect Gyr… | 2004 |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 25 years and passes through 6 companies; a new generation was cleared every 3.1 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K122818 (Olympus Keymed (Medical & Industrial Equipment) LT, 2013) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K040223.
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. 2009, 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 Gyrus ACMI® Flexible Endoscope Storage-Sterilization Trays are intended to be used to enclose and protect Gyrus ACMI flexible endoscopes during sterilization. The trays are to be used in conjunction with an FDA cleared sterilization wrap. The trays are optional accessories to the Gyrus ACMI endoscopes for which they are designed. Maintenance of sterility depends on the sterilization wrap, not the tray. The trays are indicated for ETO sterilization of…
Read the full statement (127 words)
The Gyrus ACMI® Flexible Endoscope Storage-Sterilization Trays are intended to be used to enclose and protect Gyrus ACMI flexible endoscopes during sterilization. The trays are to be used in conjunction with an FDA cleared sterilization wrap. The trays are optional accessories to the Gyrus ACMI endoscopes for which they are designed. Maintenance of sterility depends on the sterilization wrap, not the tray.
The trays are indicated for ETO sterilization of only the following
Gyrus ACMI Flexible Endoscopes
ICN ICN-0564, ICN-0565
DUR-D DUR-D, DUR-DBA
ACN ACN-2T7, ACN-2TBA
DUR-8 DUR-S, DUR-8-BA, DUR-8E, DUR-8E-BA, DUR-8 Ultra
AUR AUR-7, AUR-735
EtO Sterilization parameters:
EtO Sterilize using 100% ethylene oxide
Temp: 55°C, Vacuum 97mmHgV, Preconditioning time 60 minutes, EtO concentration 725-750 mg/L, Exposure time 60 minutes, Humidity 35%-80%, Aeration: 12 hours @55°C
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092682 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092682: Gyrus Acmi Flexible Endoscope Storage-Sterilization Trays.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092682
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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