Cleared Traditional

K153540 - Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators

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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Namsa
BRIAN EDWARDS

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FRG Wrap, Sterilization

All 261
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K153540.
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