Cleared Traditional

K180139 - Safe Secure Sterilization Pouches and R...

K180139 is the FDA 510(k) clearance for Safe Secure Sterilization Pouches and R... by Safe Secure Packing Co., Ltd.. It is a Class 2 General Hospital device (product code FRG) cleared through the Traditional 510(k) pathway after a 350-day FDA review.

K180139 · Safe Secure Packing Co., Ltd. · General Hospital
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Jan 2019
Decision
350d
Days
Class 2
Risk

K180139 is an FDA 510(k) clearance for the Safe Secure Sterilization Pouches and Rolls. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Safe Secure Packing Co., Ltd. (Dongguan City, CN). The FDA issued a Cleared decision on January 3, 2019 after a review of 350 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 Safe Secure Packing Co., Ltd. devices

Submission Details

510(k) Number K180139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2018
Decision Date January 03, 2019
Days to Decision 350 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
221d slower than avg
Panel avg: 129d · This submission: 350d
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 K180139.
JAMBRO Single Core A Sterilization wrap
K182656 · Jiangsu Zhande Medical Supplies Co., Ltd. · Jun 2019
HALYARD SMART-FOLD* Sterilization Wrap (H450, H650)
K181959 · Owens & Minor Halyard, Inc. · Mar 2019
Vis-U-All Low Temperature Sterilization Pouch/Tubing
K183401 · STERIS Corporation · Mar 2019
Vis-U-All Low Temperature Sterilization Pouch/Tubing
K183297 · STERIS Corporation · Jan 2019
Cardinal Health Sterilization Wrap
K181174 · Cardinal Health200, LLC · Dec 2018
BH Sterilization Pouch
K172280 · Bh Medical Products Co., Ltd. · Aug 2018