510(k) · Cleared
ClearedInstrument Case
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cochlear Americas · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Aug 24, 2023 as substantially equivalent to K223672 (Cochlear, 2023) after an 84-day review. Its family tree reaches back 11 generations to 1984.
- Decided
- Aug 24, 2023
- Review
- 84 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K844002 (1984). 17 ancestors in all. No later device cites it as a predicate yet.
- Root · 11 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 7 generations between
- 3 generations backK180791 Straumann BLX Surgical CassetteInstitut Straumann AG · 2018
- 2 generations backK212281 Surgical TraysDentsply Sirona, Inc. · 2022
- 1 generation backK223672 Instrument Case P1340904Cochlear · 2023
- This deviceK231604 Instrument CaseCochlear Americas · 2023
Show all 11 generations
- Root · 11 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 10 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 9 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 8 generations backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- 7 generations backK040223 Polyvac Instrument Delivery SystemSymmetry Medical USA, Inc. · 2004
- 6 generations backK120947 THS Instrument TrayHologic, Inc. · 2012
- 5 generations backK152241 Medtronic Transportation/Sterilization CassettesMedtronic Sofamor Danek USA, Inc. · 2016
- 4 generations backK163600 Kit Boxes and Kit PlatesNobel Biocare AB · 2018
- 3 generations backK180791 Straumann BLX Surgical CassetteInstitut Straumann AG · 2018
- 2 generations backK212281 Surgical TraysDentsply Sirona, Inc. · 2022
- 1 generation backK223672 Instrument Case P1340904Cochlear · 2023
- This deviceK231604 Instrument CaseCochlear Americas · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −10 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −9 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −8 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| −7 | K040223 | Polyvac Instrument Delivery System | Symmetry Medical USA, Inc. | 2004 | — |
| −6 | K120947 | THS Instrument Tray | Hologic, Inc. | 2012 | — |
| −5 | K152241 | Medtronic Transportation/Sterilization Cassettes | Medtronic Sofamor Danek USA, Inc. | 2016 | — |
| −4 | K163600 | Kit Boxes and Kit Plates | Nobel Biocare AB | 2018 | — |
| −3 | K180791 | Straumann BLX Surgical Cassette | Institut Straumann AG | 2018 | — |
| −2 | K212281 | Surgical Trays | Dentsply Sirona, Inc. | 2022 | — |
| −1 | K223672 | Instrument Case P1340904 | Cochlear | 2023 | — |
| 0 (this device) | K231604 | Instrument Case | Cochlear Americas | 2023 | — |
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 |
| 2013 | 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 |
|---|---|---|---|
| * | K223672 | Instrument Case P1340904Summary page 4…21 CFR 880.6850, Class II Classification Panel: Orthopedic Product Code: KCT 510(k): K223672 Page 1 of 9 E. Purpose of Submission This Special 510(k) seeks clea… | 2023 |
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 12 companies; a new generation was cleared every 2.2 years on median.
- None of the 17 ancestors has a recall.
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 Instrument Case is intended for staff involved in reprocessing of reusable instruments, and for surgical teams.
The product shall only be used:
• in a controlled surgical environment under sterile conditions such as a hospital,
• in reprocessing environment at sterilization departments or reprocessing centers,
• and for transport of surgical instruments.
Sterilization parameters:
In US: Pre-Vacuum Steam at 132 °C (270 °F) for 4 min with a 20 minutes dry time
Outside US: See the Reprocessing Guide available in your country
The worse-case validated load for the Instrument Case, including instruments, is 1700 g.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231604 · printed Nov 5, 2026
Cite this page
510(k) Report. “K231604: Instrument Case.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231604
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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