# K142630: Instru-Safe Instrument Protection System

- Pathway: 510(k) (Traditional)
- Applicant: Summit Medical, Inc.
- Decided: Dec 23, 2014 after 97 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 pre-vacuum steam sterilization cycle. The Instru-Safe Instrument Protection System cassettes are intended to be used in conjunction with a legally marketed Genesis rigid containers. 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. Lumen claims for Four (4) Minute Pre-Vacuum Steam Sterilization Cycle: Summit Cassette Model | Minimum Inside Diameter | Maximum Length | Number of Lumens IN-2681 | 3mm | 200mm | 1 IN-2681 | 1mm | 65mm | 1 IN-0000 | 1mm | 400mm | 5 IN-0000 | 3mm | 400mm | 1 IN-0000 | 5mm | 400mm | 1 IN-6105 | 5mm | 241mm | 1 The worst case validated load by vent-to-volume calculation is the IN-2681 tray. The total weight of the container system (e.g. container, tray and instrument load) must not exceed 25 lbs.

Source page: https://510kreport.com/device/K142630
Methodology: https://510kreport.com/methodology