# K150698: Gemini Sterilization Wrap

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Nov 20, 2015 after 247 days
- Product code: FRG (Wrap, Sterilization)
- 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: 4 generations back to K881471 (1988). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112805: Kimguard One-Step Sterilization Wrap, Kimberly-Clark Corp. (2012) Summary page 6.

## Most influential descendants
- K162993: Gemini Sterilization Wrap (2017), 0 descendants of its own

## Indications for use
The Gemini Single Ply and Bonded Sterilization Wraps are intended to allow sterilization of the enclosed medical devices(s) and also maintain sterility of the enclosed medical device(s) within the period of time for which performance data demonstrating maintenance of sterility has been provided. The Gemini Single Ply and Bonded Sterilization Wraps have been validated for use with Lumen, Non Lumen, and Flexible Cycles by the STERIS Amsco® V-PRO™ 1, Amsco® V-PRO™ 1 Plus, and Amsco® V-PRO™ maX Low Temperature Sterilization Systems. Table 1 provides a listing of validated sterilization cycles Table 2 provides recommended weights for each wrap model Table 3 provides maintenance of package sterility recommendations

Source page: https://510kreport.com/device/K150698
Methodology: https://510kreport.com/methodology