# K201878: ST-Z5

- Pathway: 510(k) (Traditional)
- Applicant: Z-Systems AG
- Decided: Mar 25, 2021 after 261 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: 9 generations back to K844002 (1984). 12 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171713: Neodent Instrument Kits, Jjgc Industria E Comercio DE Materiais Dentarios S.A. (2018) Summary page 4.

## Most influential descendants
- K243425: Guided DAS Surgical Kit (2025), 0 descendants of its own
- K243317: NUVENTUS NV.C™ Surgical Cassette and Tray (2025), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K201878
Methodology: https://510kreport.com/methodology