Cleared Traditional

K182656 - JAMBRO Single Core A Sterilization wrap

K182656 is the FDA 510(k) clearance for JAMBRO Single Core A Sterilization wrap by Jiangsu Zhande Medical Supplies Co., Ltd.. It is a Class 2 General Hospital device (product code FRG) cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K182656 · Jiangsu Zhande Medical Supplies Co., Ltd. · General Hospital
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Jun 2019
Decision
259d
Days
Class 2
Risk

K182656 is an FDA 510(k) clearance for the JAMBRO Single Core A Sterilization wrap. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Jiangsu Zhande Medical Supplies Co., Ltd. (Nanjing, CN). The FDA issued a Cleared decision on June 11, 2019 after a review of 259 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 Jiangsu Zhande Medical Supplies Co., Ltd. devices

Submission Details

510(k) Number K182656 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2018
Decision Date June 11, 2019
Days to Decision 259 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
130d slower than avg
Panel avg: 129d · This submission: 259d
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

Mdi Consultants, Inc.
Jigar Shah

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 K182656.
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
Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat Sealing Sterilization Pouch Roll Flat, Heat Sealing Sterilization Pouch Roll Gusseted
K181957 · Tianchang Jiarui Packaging Material Co., Ltd. · Jul 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
Safe Secure Sterilization Pouches and Rolls
K180139 · Safe Secure Packing Co., Ltd. · Jan 2019