510(k) · Cleared
ClearedGuided DAS Surgical Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Talladium España, SL · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Jul 22, 2025 as substantially equivalent to K201878 (Z-Systems AG, 2021) after a 260-day review. Its family tree reaches back 10 generations to 1984.
- Decided
- Jul 22, 2025
- Review
- 260 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 deviceK243425 Guided DAS Surgical KitTalladium España, SL · 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 deviceK243425 Guided DAS Surgical KitTalladium España, SL · 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) | K243425 | Guided DAS Surgical Kit | Talladium España, SL | 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…Division Division of Health Technology 4 C (Infection Control Devices) 3. PREDICATE DEVICE INFORMATION Primary predicate device is: K201878, ST-Z5, Z-Systems AG. Page 1 of 4… | 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?
Guided DAS Surgical Kit is intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Guided DAS Surgical Kit is intended to allow sterilization of the enclosed medical devices. Guided DAS Surgical Kit requires the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices. The kit is to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycle, and moist heat…
Read the full statement (155 words)
Guided DAS Surgical Kit is intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Guided DAS Surgical Kit is intended to allow sterilization of the enclosed medical devices.
Guided DAS Surgical Kit requires the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.
The kit is to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycle, and moist heat (steam) sterilized using the following cycle: dynamic air removal steam sterilization- Exposure at 132 °C for 4 minutes and 30 minutes dry time.
Guided DAS Surgical Kit is intended for sterilization of non-porous loads.
Guided DAS Surgical Kit is recommended not to be stacked during sterilization.
The combined weight of the Guided DAS Surgical Kit and the associated instruments is 760 grams.
The weight of the empty Guided DAS Surgical Kit is 600 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/K243425 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243425: Guided DAS Surgical Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243425
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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