Cleared Traditional

K222151 - Sterilization Wrap

K222151 is an FDA 510(k) clearance for Sterilization Wrap, manufactured by Kenpax International Limited. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K222151 · Kenpax International Limited · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2023
Decision
246d
Days
Class 2
Risk

K222151 is an FDA 510(k) clearance for the Sterilization Wrap. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Kenpax International Limited (Hong Kong, CN). The FDA issued a Cleared decision on March 23, 2023 after a review of 246 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 Kenpax International Limited devices

FDA 510(k) Submission Details - K222151

510(k) Number K222151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2022
Decision Date March 23, 2023
Days to Decision 246 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
117d slower than avg
Panel avg: 129d · This submission: 246d
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 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 142
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K222151.
Sterilization Wrap
K223600 · Wuhan Zonsen Medical Products Co., Ltd. · Aug 2023
Vis-U-All Low Temperature Sterilization Pouches
K231500 · STERIS Corporation · Aug 2023
Tyvek Roll with CI for STERLINK Sterilizer
K223025 · Plasmapp Co,., Ltd. · May 2023
Sterilization Pouch and Roll
K221875 · Qianjiang Kingphar Medical Packaging & Printing Co., Ltd. · Feb 2023
Steriking LT-Blueline Pouches with Tyvek
K221379 · Wipak OY · Jan 2023
SteriKing LT-Blueline Pouches with Tyvek
K221377 · Wipak OY · Dec 2022