# K173642: Klockner Surgical Box

- Pathway: 510(k) (Abbreviated)
- Applicant: Soadco, S.L.
- Decided: Oct 2, 2018 after 312 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: 7 generations back to K844002 (1984). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142519: InterActive Complete Surgical Tray, Implant Direct Sybron Manufacturing, LLC (2015) Summary page 5.

## Most influential descendants
- K243128: Klockner Kits (2024), 0 descendants of its own

## Indications for use
Klockner Surgical Box is a set of sterilization cassettes (thirteen different models between injection molding and machining sterilization cassettes). They all are designed to hold various dental surgical drills, instruments and/or tools in order to organize, steam sterilize and transport the instruments between uses. Their use and handling are intended for physicians and dental professionals in health care or equivalent facilities. The sterilization cassettes have to be enclosed in an FDA-cleared steam sterilizable wrap and sterilized in an FDA-cleared sterilizer according to the following cycle: x Pre-vacuum Steam at 134ºC for 4 minutes with 15 minutes drying time. The trays are intended for sterilization of metal and thermoplastic loads.

Source page: https://510kreport.com/device/K173642
Methodology: https://510kreport.com/methodology