Cleared Traditional

K071886 - SELF SEAL STERILIZATION POUCH (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K071886 · Shanghai Jianzhong Medical Packaging Co., Ltd. · General Hospital
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Dec 2007
Decision
171d
Days
Class 2
Risk

K071886 is an FDA 510(k) clearance for the SELF SEAL STERILIZATION POUCH. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Shanghai Jianzhong Medical Packaging Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on December 27, 2007 after a review of 171 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 Shanghai Jianzhong Medical Packaging Co., Ltd. devices

Submission Details

510(k) Number K071886 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2007
Decision Date December 27, 2007
Days to Decision 171 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 128d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 319
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K071886.
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