# K171520: SteriZign Signatur Device Protection System

- Pathway: 510(k) (Traditional)
- Applicant: Sterizign Precision Technologies, LLC
- Decided: Feb 7, 2018 after 259 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.
1 later device descends from it; 1 cites it directly.
0 of 3 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 4.

## Most influential descendants
- K253187: SteriBest® Sterilization Tray System (2026), 0 descendants of its own

## Indications for use
Identification: A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. SteriZign Signatur Device Cassette and Trays are used to organize, transport, store and protect between uses of surgical and other medical devices that are sterilized by a healthcare provider. SteriZign Signatur Device Cassette and Trays are intended to allow sterilization of the enclosed medical devices during a pre-vacuum steam sterilization cycles. The SteriZign Signatur Device Cassette and Trays are not intended on their own to maintain sterility. SteriZign Signatur Device Cassette and Trays have perforations and intended to be used in conjunction with legally marketed, validated FDA cleared sterilization wrap. Autoclave Sterilization Parameter Cycle: Pre-vacuum Temperature: 270°F (132°C) Exposure Time: 4 minutes Dry Time: 30 minutes The total weight of a tray (e.g. tray, insert and instruments) should never exceed 25 lbs. Validated sizes of stainless steel instrument lumens include: 1 each 1mm x 76 mm 1 each 1mm x 400 mm 1 each 2mm x 400 mm 1 each 3mm x 400 mm 1 each 5mm x 400 mm

Source page: https://510kreport.com/device/K171520
Methodology: https://510kreport.com/methodology