510(k) · Cleared
ClearedST-Z5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Z-Systems AG · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Mar 25, 2021 as substantially equivalent to K171713 (Jjgc Industria E Comercio DE Materiais Dentarios S.A., 2018) after a 261-day review. Its family tree reaches back 9 generations to 1984. 2 later devices descend from it.
- Decided
- Mar 25, 2021
- Review
- 261 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K844002 (1984). 12 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 5 generations between
- 3 generations backK142519 InterActive Complete Surgical TrayImplant Direct Sybron Manufacturing, LLC · 2015
- 2 generations backK160730 Instrument kitsAnthogyr · 2017
- 1 generation backK171713 Neodent Instrument KitsJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2018
- This deviceK201878 ST-Z5Z-Systems AG · 2021
- Descendant · cites it directly · 0 of its ownK243425 Guided DAS Surgical KitTalladium España, SL · 2025
- Descendant · cites it directly · 0 of its ownK243317 NUVENTUS NV.C™ Surgical Cassette and TrayInfinitum Eta, Ltd. · 2025
Show all 9 generations
- Root · 9 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 8 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 7 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 6 generations backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- 5 generations backK023658 Sterilization Cases and TraysCarr Metal Products, Inc. · 2003
- 4 generations backK052992 Conmed Linvatec Instrument Sterilization TrayConmed Linvatec · 2006
- 3 generations backK142519 InterActive Complete Surgical TrayImplant Direct Sybron Manufacturing, LLC · 2015
- 2 generations backK160730 Instrument kitsAnthogyr · 2017
- 1 generation backK171713 Neodent Instrument KitsJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2018
- This deviceK201878 ST-Z5Z-Systems AG · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −8 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −7 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −6 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| −5 | K023658 | Sterilization Cases and Trays | Carr Metal Products, Inc. | 2003 | — |
| −4 | K052992 | Conmed Linvatec Instrument Sterilization Tray | Conmed Linvatec | 2006 | — |
| −3 | K142519 | InterActive Complete Surgical Tray | Implant Direct Sybron Manufacturing, LLC | 2015 | — |
| −2 | K160730 | Instrument kits | Anthogyr | 2017 | — |
| −1 | K171713 | Neodent Instrument Kits | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2018 | — |
| 0 (this device) | K201878 | ST-Z5 | Z-Systems AG | 2021 | — |
| +1 | K243425 | Guided DAS Surgical Kit | Talladium España, SL | 2025 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K171713 | Neodent Instrument KitsSummary page 4…es (OHT4) Reviewing Division Division of Infection Control and Plastic Surgery Devices (DHT4B) PREDICATE DEVICE INFORMATION The primary predicate device is: K171713, Neodent Instrument Kits, JJGC Indústria e Comércio de Materiais Dentários S.A. 510(k) Summary… | 2018 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 37 years and passes through 10 companies; a new generation was cleared every 3.0 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K243425 (Talladium España, SL, 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K171713.
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. 2021, 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?
ST-Z5 surgical trays are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. ST-Z5 surgical trays are intended to allow sterilization of the enclosed medical devices. ST-Z5 surgical trays require the use of an FDA cleared wrap to maintain the sterility of the enclosed devices. The trays are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycle, and moist heat (steam)…
Read the full statement (170 words)
ST-Z5 surgical trays are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. ST-Z5 surgical trays are intended to allow sterilization of the enclosed medical devices.
ST-Z5 surgical trays require the use of an FDA cleared wrap to maintain the sterility of the enclosed devices.
The trays are to 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 20 minutes drying time.
ST-Z5 surgical trays are intended for sterilization of non-porous loads.
ST-Z5 surgical trays are recommended not to be stacked during sterilization.
The combined weight of the ST-Z5 ¢ m_c(t)_m(t) tray and the associated instruments is 441 grams.
The weight of the empty ST-Z5 ¢ m_c(t) m(t) tray is 361 grams.
The combined weight of the Z5-BL/TL tray and the associated instruments is 427 grams.
The weight of the empty Z5-BL/TL tray is 363 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/K201878 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201878: ST-Z5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201878
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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