Cleared Traditional

PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) (K242208) - FDA 510(k) Clearance

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

K242208 · Primed Medical Products, Inc. · General Hospital
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Oct 2024
Decision
70d
Days
Class 2
Risk

K242208 is an FDA 510(k) clearance for the PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600). Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Primed Medical Products, Inc. (Edmonton, CA). The FDA issued a Cleared decision on October 7, 2024 after a review of 70 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 Primed Medical Products, Inc. devices

Submission Details

510(k) Number K242208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2024
Decision Date October 07, 2024
Days to Decision 70 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
59d faster than avg
Panel avg: 129d · This submission: 70d
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 Peers - FRG Wrap, Sterilization

All 89
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K242208.
Medicom Sterilization Pouch and Reel
K243431 · Medicom Asia-Pacific Holdings Ltd. Taiwan Branch. · Feb 2025
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
Perpak™ Sterilization Tyvek Pouch
K241123 · Km Corp. · Sep 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