Cleared Traditional

K241123 - Perpak Sterilization Tyvek Pouch

K241123 is an FDA 510(k) clearance for Perpak Sterilization Tyvek Pouch, manufactured by Km Corp.. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K241123 · Km Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2024
Decision
148d
Days
Class 2
Risk

K241123 is an FDA 510(k) clearance for the Perpak™ Sterilization Tyvek Pouch. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Km Corp. (Gangwon-Do, KR). The FDA issued a Cleared decision on September 18, 2024 after a review of 148 days - within the typical 510(k) review window.

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 Km Corp. devices

FDA 510(k) Submission Details - K241123

510(k) Number K241123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2024
Decision Date September 18, 2024
Days to Decision 148 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
19d slower than avg
Panel avg: 129d · This submission: 148d
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 K241123.
CDB Hospital ® Sterilization Wrap (70 gsm)
K240438 · Comercializadora Brever · Nov 2024
Safe Secure Sterilization Pouches and Rolls
K242839 · Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. · Oct 2024
PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)
K242208 · Primed Medical Products, Inc. · Oct 2024
Medline Reusable Sterilization Wrappers
K234132 · Medline Industries, LP · Sep 2024
HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization Wrap
K234050 · O&M Halyard, Inc. · Sep 2024
HALYARD* SMART-FOLD* Sterilization Wrap (H450)
K240330 · O&M Halyard, Inc. · Aug 2024