Cleared Traditional

Sterilization Wraps (K220133) - FDA 510(k) Clearance

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

K220133 · Weihai Hongyu Nonwoven Fabric Products Co., Ltd. · General Hospital
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Optimized for regulatory review, auditing and printing
Mar 2022
Decision
51d
Days
Class 2
Risk

K220133 is an FDA 510(k) clearance for the Sterilization Wraps. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Weihai Hongyu Nonwoven Fabric Products Co., Ltd. (Weihai, CN). The FDA issued a Cleared decision on March 10, 2022 after a review of 51 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Weihai Hongyu Nonwoven Fabric Products Co., Ltd. devices

Submission Details

510(k) Number K220133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2022
Decision Date March 10, 2022
Days to Decision 51 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
78d faster than avg
Panel avg: 129d · This submission: 51d
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 89
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K220133.
HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap
K214007 · Owens & Minor (O&M) Halyard, Inc. · Jul 2022
Steriking Packaging for Medical Devices
K221016 · Wipak OY · May 2022
CareGUARD Sterilization Wrap
K213907 · Care Essentials Pty, Ltd. · Mar 2022
Steiking Packaging for Medical Devices
K210810 · Wipak OY · Jan 2022
SterileRight sterilization pouch and roll
K212338 · Sterileright Packaging Mfg., Inc. · Nov 2021
Tyvek(R) Roll with CI for STERLINKTM Sterilizer
K212198 · Plasmapp Co,., Ltd. · Oct 2021