# K133015: Instru-Safe Instrument Protection System

- Pathway: 510(k) (Traditional)
- Applicant: Summit Medical, Inc.
- Decided: Mar 13, 2014 after 169 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.
7 later devices descend from it; 5 cite it directly.
0 of 8 devices 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.

## Most influential descendants
- K171520: SteriZign Signatur Device Protection System (2018), 1 descendant of its own
- K150540: Instru-Safe Instrument Protection System (2015), 1 descendant of its own
- K253187: SteriBest® Sterilization Tray System (2026), 0 descendants of its own
- K210836: InstruSafe Instrument Protection System (2021), 0 descendants of its own
- K151166: Instru-Safe Instrument Protection System (2015), 0 descendants of its own

## 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 pre-vacuum steam sterilization cycles. 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. Autoclave Sterilization Parameter Cycle: Pre-vacuum Temperature: 270°F (132°C) Exposure Time: 4 minutes Minimum Dry Time: 30 minutes

Source page: https://510kreport.com/device/K133015
Methodology: https://510kreport.com/methodology