Cleared Traditional

K152564 - Gemini Sterilization Wrap

K152564 is an FDA 510(k) clearance for Gemini 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 302-day FDA review.

K152564 · Medline Industries, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
302d
Days
Class 2
Risk

K152564 is an FDA 510(k) clearance for the Gemini Sterilization Wrap. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on July 7, 2016 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K152564

510(k) Number K152564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2015
Decision Date July 07, 2016
Days to Decision 302 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
173d slower than avg
Panel avg: 129d · This submission: 302d
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 172
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K152564.
Cardinal Health Sterilization Wrap
K161910 · Cardinal Health200, LLC · Apr 2017
Barrier Supreme Sterilization Wrapper
K162162 · Standard Textile Co., Inc. · Nov 2016
Vis-U-All Low Temperature Sterilization Pouch/Tubing
K160908 · STERIS Corporation · Jul 2016
Gemini Bonded Sterilization Wrap
K152458 · Medline Industries, Inc. · Jun 2016
Cardinal Health Sterilization Wrap
K151445 · Cardinal Health200, LLC · Dec 2015
Sterisheet Sterilization Wrap
K152291 · Andersen Sterilizers, Inc. · Dec 2015