# K151166: Instru-Safe Instrument Protection System

- Pathway: 510(k) (Traditional)
- Applicant: Summit Medical, Inc.
- Decided: Aug 18, 2015 after 109 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: 1 generation back to K133015 (2014). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133015: Instru-Safe Instrument Protection System, Summit Medical, Inc. (2014) Summary page 9.

## 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 NX Standard Sterilization Cycle. The Instru-Safe Instrument Protection System cassettes are intended to be used in conjunction with a 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. Sterilization methods and configurations - Sterrad NX Standard Sterilization Cycle Lumen claims for Sterrad NX Standard Sterilization Cycle Summit Cassette Model Minimum Inside Diameter Maximum Length ~ Number of Lumens IN-2681 1l mm 65 mm 1 IN-2681 3 mm 200 mm | IN-8987-S 1 mm 500 mm 5 IN-8615 2.3 mm 210 mm 5 IN-6105 4 mm 235 mm 1 The worst case validated load by vent-to-volume calculation is the IN-2681 tray.

Source page: https://510kreport.com/device/K151166
Methodology: https://510kreport.com/methodology