# K192641: Gemini Titan Sterilization Wrap

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Jan 24, 2020 after 122 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: 3 generations back to K113353 (2013). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152458: Gemini Bonded Sterilization Wrap, Medline Industries, Inc. (2016) Summary page 5.

## Indications for use
Gemini Titan 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 the enclosed device until used. -Pre-vacuum steam at 270°F/132°C for 4 minutes. The wrap was validated for a dry time of 30 minutes. Gemini® Titan™ Sterilization Wrap is available in square sheets ranging from 36” x 36” to 54” x 54” and can be used with trays weighing up to 25 lbs.

Source page: https://510kreport.com/device/K192641
Methodology: https://510kreport.com/methodology