510(k) · Cleared
ClearedNUVENTUS NV.C™ Surgical Cassette and Tray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Infinitum Eta, Ltd. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Feb 11, 2025 as substantially equivalent to K201878 (Z-Systems AG, 2021) after a 112-day review. Its family tree reaches back 10 generations to 1984.
- Decided
- Feb 11, 2025
- Review
- 112 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K844002 (1984). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 6 generations between
- 3 generations backK160730 Instrument kitsAnthogyr · 2017
- 2 generations backK171713 Neodent Instrument KitsJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2018
- 1 generation backK201878 ST-Z5Z-Systems AG · 2021
- This deviceK243317 NUVENTUS NV.C™ Surgical Cassette and TrayInfinitum Eta, Ltd. · 2025
Show all 10 generations
- Root · 10 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 9 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 8 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 7 generations backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- 6 generations backK023658 Sterilization Cases and TraysCarr Metal Products, Inc. · 2003
- 5 generations backK052992 Conmed Linvatec Instrument Sterilization TrayConmed Linvatec · 2006
- 4 generations backK142519 InterActive Complete Surgical TrayImplant Direct Sybron Manufacturing, LLC · 2015
- 3 generations backK160730 Instrument kitsAnthogyr · 2017
- 2 generations backK171713 Neodent Instrument KitsJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2018
- 1 generation backK201878 ST-Z5Z-Systems AG · 2021
- This deviceK243317 NUVENTUS NV.C™ Surgical Cassette and TrayInfinitum Eta, Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −9 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −8 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −7 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| −6 | K023658 | Sterilization Cases and Trays | Carr Metal Products, Inc. | 2003 | — |
| −5 | K052992 | Conmed Linvatec Instrument Sterilization Tray | Conmed Linvatec | 2006 | — |
| −4 | K142519 | InterActive Complete Surgical Tray | Implant Direct Sybron Manufacturing, LLC | 2015 | — |
| −3 | K160730 | Instrument kits | Anthogyr | 2017 | — |
| −2 | K171713 | Neodent Instrument Kits | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2018 | — |
| −1 | K201878 | ST-Z5 | Z-Systems AG | 2021 | — |
| 0 (this device) | K243317 | NUVENTUS NV.C™ Surgical Cassette and Tray | Infinitum Eta, Ltd. | 2025 | — |
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 |
|---|---|---|---|
| * | K201878 | ST-Z5Summary page 5…ssettes & Other Accessories Regulatory Class: Class II Product Code: KCT 3. Predicate Device: Z-Systems AG’s ST-Z5, cleared under K201878. 4. Device Description The subject device is a reusable rigid container, comprising a base (bottom), a removable inner tray,… | 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 41 years and passes through 11 companies; a new generation was cleared every 3.1 years on median.
- None of the 13 ancestors has a recall.
- 1 other device also cites its predicate K201878.
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. 2025, 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 NUVENTUS NV.C™ Surgical Cassette and Tray is intended to enclose other medical devices that are to be sterilized by a health care provider. The NUVENTUS NV.C™ Surgical Cassette and Tray is intended to allow sterilization of the enclosed medical devices. The NUVENTUS NV.C™ Surgical Cassette and Tray requires the use of an FDA cleared wrap to maintain the sterility of the enclosed devices. The NUVENTUS NV.C™ Surgical Cassette and Tray should be…
Read the full statement (168 words)
The NUVENTUS NV.C™ Surgical Cassette and Tray is intended to enclose other medical devices that are to be sterilized by a health care provider. The NUVENTUS NV.C™ Surgical Cassette and Tray is intended to allow sterilization of the enclosed medical devices.
The NUVENTUS NV.C™ Surgical Cassette and Tray requires the use of an FDA cleared wrap to maintain the sterility of the enclosed devices. The NUVENTUS NV.C™ Surgical Cassette and Tray should be enclosed in a sterilization wrap that is FDA cleared for the indicated cycle, and moist heat (steam) sterilized using the following cycle: Pre-vacuum steam: 132°C (270°F) for 4 minutes with 30 minutes drying time.
The NUVENTUS NV.C™ Surgical Cassette and Tray is intended for sterilization of non-porous loads.
The NUVENTUS NV.C™ Surgical Cassette and Tray is recommended not to be stacked during sterilization. The combined weight of the NUVENTUS NV.C™ Surgical Cassette and Tray and the associated instruments is 220 grams. The weight of the empty NUVENTUS NV.C™ Surgical Cassette and Tray is 200 grams.
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/K243317 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243317: NUVENTUS NV.C™ Surgical Cassette and Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243317
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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