Cleared Traditional

K153540 - Safe Secure Sterilization Pouch with St...

K153540 is an FDA 510(k) clearance for Safe Secure Sterilization Pouch with St..., manufactured by Safe Secure Packaging Co., Ltd.. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K153540 · Safe Secure Packaging Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
238d
Days
Class 2
Risk

K153540 is an FDA 510(k) clearance for the Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Safe Secure Packaging Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on August 4, 2016 after a review of 238 days - an extended review cycle.

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 Safe Secure Packaging Co., Ltd. devices

FDA 510(k) Submission Details - K153540

510(k) Number K153540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2015
Decision Date August 04, 2016
Days to Decision 238 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
109d slower than avg
Panel avg: 129d · This submission: 238d
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 180
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K153540.
Gemini Sterilization Wrap
K162993 · Medline Industries, Inc. · Jun 2017
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 Sterilization Wrap
K152564 · Medline Industries, Inc. · Jul 2016
Gemini Bonded Sterilization Wrap
K152458 · Medline Industries, Inc. · Jun 2016