Cleared Traditional

K192641 - Gemini Titan Sterilization Wrap

K192641 is the FDA 510(k) clearance for Gemini Titan Sterilization Wrap by Medline Industries, Inc.. It is a Class 2 General Hospital device (product code FRG) cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K192641 · Medline Industries, Inc. · General Hospital
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Jan 2020
Decision
122d
Days
Class 2
Risk

K192641 is an FDA 510(k) clearance for the Gemini Titan Sterilization Wrap. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Northfiled, US). The FDA issued a Cleared decision on January 24, 2020 after a review of 122 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Medline Industries, Inc. devices

Submission Details

510(k) Number K192641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2019
Decision Date January 24, 2020
Days to Decision 122 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 129d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRG Wrap, Sterilization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FRG Wrap, Sterilization

All 118
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K192641.
Tyvek Sterilization Pouches with Chevron Seal
K200336 · Andersen Sterilizers, Inc. · Nov 2020
Turbett Instrument Pod
K200240 · Turbett Surgical, Inc. · Apr 2020
Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch
K193561 · Weihai Xingtai Packaging Products Co., Ltd. · Apr 2020
Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted)
K182184 · Mdk (Shanghai) Medical Packing Co., Ltd. · Oct 2019
Halyard ONE-STEP* Sterilization Wrap
K192147 · Owens & Minor (O&M) Halyard, Inc. · Oct 2019
Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch
K183356 · Weihai Xingtai Packaging Products Co., Ltd. · Aug 2019