# K140289: Instru-Safe Instrument Protection System

- Pathway: 510(k) (Traditional)
- Applicant: Summit Medical, Inc.
- Decided: Jun 27, 2014 after 142 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Instru-Safe Instrument Protection System cassettes are used to organize and protect other medical devices that are sterilized by a healthcare provider. Instru-Safe Instrument Protection System cassettes are intended to allow sterilization of the enclosed medical devices during Sterrad 100S Standard and Sterrad 100NX Standard sterilization cycles. The Instru-Safe Instrument Protection System cassettes are intended to be used in conjunction with legally marketed wrap or Aesculap rigid container. The Instru-Safe Instrument Protection System cassettes are not intended on their own to maintain sterility. A full list of device models is provided in Table 1. The following sterilization trays were validated with the corresponding rigid containers: * Sterrad 100S Standard Cycle * Sterrad 100NX Standard Cycle * Validated by Summit Medical for use in Sterrad 100S Standard Cycle and Sterrad 100NX Standard Cycle ONLY. Consult container instructions to ensure that contents do not exceed the sterilization containers’ intended load claims. Lumen claims for Sterrad 100S Standard and Sterrad 100NX Standard Cycles: 4 stainless steel lumens with 3 mm inner diameter x 400 mm length 2 stainless steel lumens with 3 mm inner diameter x 200 mm length 1 stainless steel lumen with 3 mm inner diameter x 200 mm length: IN-2681 1 stainless steel lumen with 1 mm inner diameter x 65 mm length

Source page: https://510kreport.com/device/K140289
Methodology: https://510kreport.com/methodology