# K141513: Instru-Safe Instrument Protection System

- Pathway: 510(k) (Traditional)
- Applicant: Summit Medical, Inc.
- Decided: Dec 15, 2014 after 189 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 a Sterrad® 100NX Express Cycle. The Instru-Safe Instrument Protection System cassettes are intended to be used in conjunction with a legally marketed wrap. The Instru-Safe Instrument Protection System cassettes are not intended on their own to maintain sterility. The Instru-Safe Instrument Protection System has no lumen claims for the Sterrad 100NX Express Cycle.

Source page: https://510kreport.com/device/K141513
Methodology: https://510kreport.com/methodology