Cleared Traditional

K182184 - Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted)

K182184 is an FDA 510(k) clearance for Paper Sterilization Pouch and Roll(Ster..., manufactured by Mdk (Shanghai) Medical Packing Co., Ltd.. The device is a Class 2 General Hospital device with 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
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K182184

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.

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 240
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