510(k) · Cleared
ClearedDental, Medical Instrument Cases & Cassette
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sterilization Cassette Systems, Inc. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Mar 7, 1997 after a 252-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 180 devices in its family, counting itself, has a Class I recall. 179 later devices descend from it.
- Decided
- Mar 7, 1997
- Review
- 252 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 0
179 later devices descend from it, 2 citing it directly. 1 of the 180 devices in this family, counting this one, has a Class I recall.
- This deviceK962545 Dental, Medical Instrument Cases & CassetteSterilization Cassette Systems, Inc. · 1997
- Descendant · cites it directly · 152 of its ownK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- Descendant · 2 generations on · 150 of its ownK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- Descendant · 2 generations on · 149 of its ownK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- Descendant · 3 generations on · 58 of its ownK033222 Olympus Sterilization TraysOlympus Winter & Ibe GmbH · 2004
- Descendant · 3 generations on · 46 of its ownK040223 Polyvac Instrument Delivery SystemSymmetry Medical USA, Inc. · 2004
Showing 5 of 179 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K050220 Evis Exera Bronchovideoscope, Olympus…4 generations on · 2005
Most influential descendants
Showing 5 of 179 · See all- K980065C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998 · cites it directly152descendants
- K990761Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999 · 2 generations on150descendants
- K012105Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002 · 2 generations on149descendants
- K033222Olympus Sterilization TraysOlympus Winter & Ibe GmbH · 2004 · 3 generations on58descendants
- K040223Polyvac Instrument Delivery SystemSymmetry Medical USA, Inc. · 2004 · 3 generations on46descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962545 | Dental, Medical Instrument Cases & Cassette | Sterilization Cassette Systems, Inc. | 1997 | — |
| +1 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| +2 | 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 | — |
| +3 | K033222 | Olympus Sterilization Trays | Olympus Winter & Ibe GmbH | 2004 | — |
| +3 | K040223 | Polyvac Instrument Delivery System | Symmetry Medical USA, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 1 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 6 | 0 |
| 2009 | 3 | 0 |
| 2010 | 9 | 0 |
| 2011 | 3 | 0 |
| 2012 | 6 | 0 |
| 2013 | 7 | 0 |
| 2014 | 5 | 0 |
| 2015 | 4 | 0 |
| 2016 | 7 | 0 |
| 2017 | 7 | 0 |
| 2018 | 12 | 0 |
| 2019 | 15 | 0 |
| 2020 | 12 | 0 |
| 2021 | 19 | 0 |
| 2022 | 12 | 0 |
| 2023 | 10 | 0 |
| 2024 | 9 | 0 |
| 2025 | 12 | 0 |
| 2026 | 6 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (179)
See all 1792 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K050220Evis Exera Bronchovideoscope, Olympus XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2ACOlympus Medical Systems Corporation · 2005 · 4 generations on · ◆ in the 2005 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K980065 (C/T Med System, Ltd., 1998) has gone furthest, with 152 descendants of its own.
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.
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 | — |
https://510kreport.com/device/K962545 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962545: Dental, Medical Instrument Cases & Cassette.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962545
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026