510(k) · Cleared
ClearedAnthogyr Surgical Cassettes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Anthogyr · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Jul 11, 2023 as substantially equivalent to K160730 (Anthogyr, 2017) after a 120-day review. Its family tree reaches back 8 generations to 1984.
- Decided
- Jul 11, 2023
- Review
- 120 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K844002 (1984). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 7 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 6 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 5 generations backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- 4 generations backK023658 Sterilization Cases and TraysCarr Metal Products, Inc. · 2003
- 3 generations backK052992 Conmed Linvatec Instrument Sterilization TrayConmed Linvatec · 2006
- 2 generations backK142519 InterActive Complete Surgical TrayImplant Direct Sybron Manufacturing, LLC · 2015
- 1 generation backK160730 Instrument kitsAnthogyr · 2017
- This deviceK230680 Anthogyr Surgical CassettesAnthogyr · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −7 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −6 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −5 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| −4 | K023658 | Sterilization Cases and Trays | Carr Metal Products, Inc. | 2003 | — |
| −3 | K052992 | Conmed Linvatec Instrument Sterilization Tray | Conmed Linvatec | 2006 | — |
| −2 | K142519 | InterActive Complete Surgical Tray | Implant Direct Sybron Manufacturing, LLC | 2015 | — |
| −1 | K160730 | Instrument kits | Anthogyr | 2017 | — |
| 0 (this device) | K230680 | Anthogyr Surgical Cassettes | Anthogyr | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 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 |
|---|---|---|---|
| * | K160730 | Instrument kitsSummary page 5…Anthogyr Surgical Cassettes 510(k) Summary Predicate Device(s) Primary Predicate: • K160730 – Instrument Kits (Anthogyr) Classification Name: Sterilization Wrap Containers, Trays, Cassettes & Other Acc… | 2017 |
| † | K203618 | Neodent EasyGuide Kit Cases | 2021 |
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 39 years and passes through 8 companies; a new generation was cleared every 3.6 years on median.
- None of the 11 ancestors has a recall.
- 1 other device also cites its predicate K160730.
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. 2023, 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 Anthogyr Surgical Cassettes are designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and protect the instruments that are sterilized by healthcare provider. The cassette is to be enclosed in an FDA cleared steam sterilizable pouch. The cassettes are not intended on their own to maintain sterility. The cycle of sterilization is: INMODOPS3, INMODOPS3L, INMODOPP3, INMODIGM, INMODOPS3V, INMODOPS3LV, INMODOPP3V…
Read the full statement (138 words)
The Anthogyr Surgical Cassettes are designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and protect the instruments that are sterilized by healthcare provider. The cassette is to be enclosed in an FDA cleared steam sterilizable pouch. The cassettes are not intended on their own to maintain sterility.
The cycle of sterilization is:
INMODOPS3, INMODOPS3L, INMODOPP3, INMODIGM, INMODOPS3V, INMODOPS3LV, INMODOPP3V, INMODIGMV: Pre-vacuum steam: 132 °C (270º F) during 4 minutes with 20 minutes drying time
The Anthogyr Surgical Cassettes have been validated for a maximum load of with the associated instruments:
The worst-case recommended load is 412g.
The device dimensions are listed below for Anthogyr Surgical Cassettes:
- INMODOPS3, INMODOPS3V, INMODOPS3L, INMODOPS3LV, INMODOPP3, INMODOPP3V: 130x155x47 mm
- INMODIGM, INMODIGMV: 76x155x47 mm
The cassettes are not intended to be stacked during sterilization process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230680 · printed Nov 4, 2026
Cite this page
510(k) Report. “K230680: Anthogyr Surgical Cassettes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230680
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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