Cleared Traditional

K223025 - Tyvek Roll with CI for STERLINK Sterilizer

K223025 is an FDA 510(k) clearance for Tyvek Roll with CI for STERLINK Sterilizer, manufactured by Plasmapp Co,., Ltd.. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 222-day FDA review.

K223025 · Plasmapp Co,., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2023
Decision
222d
Days
Class 2
Risk

K223025 is an FDA 510(k) clearance for the Tyvek Roll with CI for STERLINK Sterilizer. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Plasmapp Co,., Ltd. (Daejeon, KR). The FDA issued a Cleared decision on May 9, 2023 after a review of 222 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 Plasmapp Co,., Ltd. devices

FDA 510(k) Submission Details - K223025

510(k) Number K223025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2022
Decision Date May 09, 2023
Days to Decision 222 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d slower than avg
Panel avg: 129d · This submission: 222d
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 147
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K223025.
Steriking® LT-Blueline Pouches with Tyvek®
K231999 · Wipak OY · Sep 2023
Sterilization Wrap
K223600 · Wuhan Zonsen Medical Products Co., Ltd. · Aug 2023
Vis-U-All Low Temperature Sterilization Pouches
K231500 · STERIS Corporation · Aug 2023
Sterilization Wrap
K222151 · Kenpax International Limited · Mar 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