Cleared Traditional

K192641 - Gemini Titan Sterilization Wrap

K192641 is an FDA 510(k) clearance for Gemini Titan Sterilization Wrap, manufactured by Medline Industries, Inc.. The device is a Class 2 General Hospital device with 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

FDA 510(k) Submission Details - K192641

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.

FRG Device Classification - Class 2, Special Controls

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 226
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