Cleared Traditional

K181957 - Heat Sealing Sterilization Pouch Flat

K181957 is the FDA 510(k) clearance for Heat Sealing Sterilization Pouch Flat by Tianchang Jiarui Packaging Material Co., Ltd.. It is a Class 2 General Hospital device (product code FRG) cleared through the Traditional 510(k) pathway after a 351-day FDA review.

K181957 · Tianchang Jiarui Packaging Material Co., Ltd. · General Hospital
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Jul 2019
Decision
351d
Days
Class 2
Risk

K181957 is an FDA 510(k) clearance for the Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusse.... Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Tianchang Jiarui Packaging Material Co., Ltd. (Tianchang, CN). The FDA issued a Cleared decision on July 9, 2019 after a review of 351 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 Tianchang Jiarui Packaging Material Co., Ltd. devices

Submission Details

510(k) Number K181957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2018
Decision Date July 09, 2019
Days to Decision 351 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
222d slower than avg
Panel avg: 129d · This submission: 351d
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 Consultant

Beijing Believe-Med Technology Service Co., Ltd.
Ray Wang

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 122
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K181957.
Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted)
K182184 · Mdk (Shanghai) Medical Packing Co., Ltd. · Oct 2019
Halyard ONE-STEP* Sterilization Wrap
K192147 · Owens & Minor (O&M) Halyard, Inc. · Oct 2019
Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch
K183356 · Weihai Xingtai Packaging Products Co., Ltd. · Aug 2019
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