Cleared Traditional

K182184 - Paper Sterilization Pouch and Roll(Ster...

K182184 is the FDA 510(k) clearance for Paper Sterilization Pouch and Roll(Ster... by Mdk (Shanghai) Medical Packing Co., Ltd.. It is a Class 2 General Hospital device (product code FRG) cleared through the Traditional 510(k) pathway after a 423-day FDA review.

K182184 · Mdk (Shanghai) Medical Packing Co., Ltd. · General Hospital
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Optimized for regulatory review, auditing and printing
Oct 2019
Decision
423d
Days
Class 2
Risk

K182184 is an FDA 510(k) clearance for the Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Po.... Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Mdk (Shanghai) Medical Packing Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on October 10, 2019 after a review of 423 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Mdk (Shanghai) Medical Packing Co., Ltd. devices

Submission Details

510(k) Number K182184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2018
Decision Date October 10, 2019
Days to Decision 423 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
294d slower than avg
Panel avg: 129d · This submission: 423d
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 Peers - FRG Wrap, Sterilization

All 122
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K182184.
Turbett Instrument Pod
K200240 · Turbett Surgical, Inc. · Apr 2020
Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch
K193561 · Weihai Xingtai Packaging Products Co., Ltd. · Apr 2020
Gemini Titan Sterilization Wrap
K192641 · Medline Industries, Inc. · Jan 2020
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