# K051157: Instru-Safe Instrument Protection Systems

- Pathway: 510(k) (Traditional)
- Applicant: Micromedics, Inc.
- Decided: Sep 1, 2005 after 119 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 System cassettes are intended to allow sterilization of the enclosed medical devices during a pre-vacuum steam or ethylene oxide sterilization cycles. The Instru-Safe System cassettes are intended to be used in conjunction with central legally marketed wrap or with a Genesis rigid container. The Instru-Safe System cassettes are not intended on the own to maintain sterility. Sterilization methods and configurations Steam 140 count woven wrap: 10 minute dry time Non-woven wrap (Kimberly Clark): 50 minute dry time Genesis Container: 30 minute dry time 8 minute preconditioning at 132°C Ethylene Oxide (EO): 1 hour preconditioning at 131 °F (55 °C) with relative Humidity of 70±15%; 2 hours exposure at 131 °F (55 °C); 12 hours aeration

Source page: https://510kreport.com/device/K051157
Methodology: https://510kreport.com/methodology