Cleared Traditional

K062704 - STERILIZATION POUCH WITH INDICATORS

K062704 is an FDA 510(k) clearance for STERILIZATION POUCH WITH INDICATORS, manufactured by Winner Industries (Shenzhen) Co., Ltd.. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K062704 · Winner Industries (Shenzhen) Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
270d
Days
Class 2
Risk

K062704 is an FDA 510(k) clearance for the STERILIZATION POUCH WITH INDICATORS. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Winner Industries (Shenzhen) Co., Ltd. (Pomona, US). The FDA issued a Cleared decision on June 8, 2007 after a review of 270 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 Winner Industries (Shenzhen) Co., Ltd. devices

FDA 510(k) Submission Details - K062704

510(k) Number K062704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2006
Decision Date June 08, 2007
Days to Decision 270 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
141d slower than avg
Panel avg: 129d · This submission: 270d
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 123
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K062704.
KIMGUARD STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500 AND KC600
K082554 · Kimberly-Clark Corp. · May 2009
KIMGUARD ONE-STEP STERILIZATION WRAP
K082177 · Kimberly-Clark Corp. · Mar 2009
VIS-U-ALL II HEAT-SEAL POUCH AND TUBING
K071087 · STERIS Corporation · Oct 2007
AESCULAP STERILCONTAINER SYSTEM
K053389 · Aesculap, Inc. · Feb 2006
REUSABLE STERILCONTAINER FILTER MODEL #JK090
K041623 · Aesculap, Inc. · Dec 2004
APTIMAX INSTRUMENT TRAY, INSTRUMENT MAT AND INSTRUMENT HOLDER
K013003 · Advanced Sterilization Products · Aug 2002