# K180528: InstruSafe (R) Sterilization Container

- Pathway: 510(k) (Traditional)
- Applicant: Summit Medical, Inc.
- Decided: Nov 16, 2018 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: 6 generations back to K991023 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123234: Ermis Sterilization Container System, Ermis Medizintechnik (2013) Summary page 6.

## Indications for use
The InstruSafe® Sterilization Container is a reusable sterilization container system intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed device and also maintain sterility for 180 days. The InstruSafe® Sterilization Container includes accessories such as trays, baskets, filters, data cards and tamper proof locks. The InstruSafe® Sterilization Container consists of various models within the validated product line. All models are available with perforated lids and either perforated or non-perforated bottoms. All models are intended to be used with single use paper filters. The container is a reusable device designed to be used with the following sterilization cycle parameters: Pre-Vacuum Steam Sterilization Cycle: 4 minutes 1320C (270 oF) Drying Time Minimum: 30 minutes Model Number | Description Total Container Loaded | Load Description Maximum Weight (Ibs) CS-3XXX Full 1/1 Perforated Container Lid Not applicable Metal (Stainless Steel) CS-3XXX Full 1/1 Container Bottom 25 Ibs surgical instruments CS-2XXX Three quarter % Perforated Container Lid | Not applicable like forceps, scissors, CS-2XXX Three quarter % Container Bottom 25 Ibs clamps, etc. including CS-1XXX One half % Perforated Container Lid Not applicable lumened /cannulated CS-1XXX One half ¥ Container Bottom 18 Ibs Instruments. CS-5XXX XL Perforated Container Lid Not applicable CS-5XXX XL Container Bottom 25 lbs

Source page: https://510kreport.com/device/K180528
Methodology: https://510kreport.com/methodology