510(k) · Cleared
ClearedGyrus Acmi Cyber Wand-Sterilization Trays Model FGT
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 May 20, 2011 as substantially equivalent to K092682 (Gyrus Acmi, Inc., 2009) and 1 other predicate after a 226-day review. Its family tree reaches back 6 generations to 1984.
- Decided
- May 20, 2011
- Review
- 226 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. 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 deviceK102970 Gyrus Acmi Cyber Wand-Sterilization Trays Model FGTGyrus Acmi, Inc. · 2011
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) | 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 |
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 |
|---|---|---|---|
| * | K092682 | Gyrus Acmi Flexible Endoscope Storage-Sterilization TraysSummary page 1…and Transducer and Accessories Sterilization Trays Generic/Common Name: Sterilization trays Predicate Devices Gyros ACMI Flexible Endoscope Storage Sterilization Trays K092682 ¢ Symmetry Medical PolyVac Instrument Delivery System K040223 Intended Uses The Gyrus ACMI® CyberWand™ Transducer and Accessorie… | 2009 |
| * | K040223 | Polyvac Instrument Delivery SystemSummary page 1…mmon Name: Sterilization trays Predicate Devices Gyros ACMI Flexible Endoscope Storage Sterilization Trays K092682 ¢ Symmetry Medical PolyVac Instrument Delivery System K040223 Intended Uses The Gyrus ACMI® CyberWand™ Transducer and Accessories Storage-Sterilization Trays are intended to be used to enclo… | 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 27 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. 2011, 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 CyberWand™ Sterilization Trays are intended to be used to enclose and protect only CyberWand™ transducers and accessories during sterilization. The trays are to be used in conjunction with an FDA cleared sterilization wrap. The trays are optional accessories to the CyberWand™ transducers and accessories for which they are designed. The trays are indicated for ETO sterilization of only the following (maximum load) per tray: 2 CyberWand…
Read the full statement (112 words)
The Gyrus ACMI CyberWand™ Sterilization Trays are intended to be used to enclose and protect only CyberWand™ transducers and accessories during sterilization. The trays are to be used in conjunction with an FDA cleared sterilization wrap. The trays are optional accessories to the CyberWand™ transducers and accessories for which they are designed.
The trays are indicated for ETO sterilization of only the following (maximum load) per tray: 2 CyberWand Transducers, 2 CyberWand Probe sets, 1 Wrench, 1 Cleaning stylet.
EtO Sterilization parameters: EtO Sterilize using 100% ethylene oxide: Temp 55 °C, Vacuum 97mmHgV, Preconditioning time 60 minutes, EtO concentration 735-750 mg/L, Exposure time 60 minutes, Humidity 35%-80%, Aeration 12 hours @55 °C.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K102970 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102970: Gyrus Acmi Cyber Wand-Sterilization Trays Model FGT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102970
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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