# K152458: Gemini Bonded Sterilization Wrap

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Jun 1, 2016 after 278 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: 2 generations back to K113353 (2013). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143147: Gemini Bonded Sterilization Wrap, Medline Industries, Inc. (2015) Summary page 7.

## Most influential descendants
- K192641: Gemini Titan Sterilization Wrap (2020), 0 descendants of its own

## Indications for use
Gemini Bonded Sterilization Wraps are 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 such content until used. Gemini Bonded Sterilization Wrap is validated for use in steam or STERRAD sterilization processes in the following sterilization modes and cycles:

Source page: https://510kreport.com/device/K152458
Methodology: https://510kreport.com/methodology