# K243425: Guided DAS Surgical Kit

- Pathway: 510(k) (Traditional)
- Applicant: Talladium España, SL
- Decided: Jul 22, 2025 after 260 days
- Product code: KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K844002 (1984). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201878: ST-Z5, Z-Systems AG (2021) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K243425
Methodology: https://510kreport.com/methodology