# K123234: Ermis Sterilization Container System

- Pathway: 510(k) (Traditional)
- Applicant: Ermis Medizintechnik
- Decided: Jul 5, 2013 after 263 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: 5 generations back to K991023 (2000). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091720: Sklarlite Rigid Sterilization Container System, Sklar Corp. (2010) Summary page 2.

## Cited in the summary but kept off the family tree
- K121909: Inspire 6 Dual Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy Reservior, Sorin Group Italia S.R.L. (2012). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K180528: InstruSafe (R) Sterilization Container (2018), 0 descendants of its own

## Indications for use
The ERMIS Sterilization Container System Is Intended to allow sterilization of the enclosed medical device and also maintain sterility during transport and storage for 30 days. The system consists of different models, such as 1/1 Size, % Size, %1size, mini and dental containers which may vary in size, perforations and color. All models are available with perforated lids and either perforated or non-perforated bottoms. To enable proper organization of sterilized goods, different wire- or sleeve baskets exactly adapted to the specific container dimensions are available. All models are intended to be used with Ermis single use paper filters. The containers are reusable devices designed to be used with the following sterilization cycle parameters: Pre Vacuum cycle: 4 minutes 3 minutes 132 0 C (270-F) 135-C (273-F) Drying Time minimum 20 minutes Drying Time minimum 16 minutes Loading: Metal surgical instruments (scissors, clamps, forceps) and textiles

Source page: https://510kreport.com/device/K123234
Methodology: https://510kreport.com/methodology