# K113353: Gemini Sterilzation Wrap

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Jan 31, 2013 after 444 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
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 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
- K143147: Gemini Bonded Sterilization Wrap (2015), 2 descendants of its own
- K152458: Gemini Bonded Sterilization Wrap (2016), 1 descendant of its own
- K192641: Gemini Titan Sterilization Wrap (2020), 0 descendants of its own
- K152564: Gemini Sterilization Wrap (2016), 0 descendants of its own

## Indications for use
Gemini Sterilization Wrap is 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 for 180 days following sterilization. Gemini Sterilization Wrap is validated for use in steam or STERRAD' sterilization processes in the following sterilization modes and cycles. * Pre-vacuum steam cycles o 4 Minutes Exposure at 270 0F/1320 C with minimum 20 minutes dry time * Gravity steam cycles o 30 Minutes Exposure at 2500 F/1210 C with minimum 20 minutes dry time * STERRADO Sterilization o STERRADO IOONX, Flex cycle o STERRADt IOONX, Standard cycle o STERRADO 100ONX, Express cycle o STERRADO 100S, Standard cycle o STERRAD t NX, Advanced cycle o STERRAD®NX, Standard cycle

Source page: https://510kreport.com/device/K113353
Methodology: https://510kreport.com/methodology