Cleared Traditional

Medicom Sterilization Wrap (K240862) - FDA 510(k) Clearance

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

K240862 · Medicom Group, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2024
Decision
85d
Days
Class 2
Risk

K240862 is an FDA 510(k) clearance for the Medicom Sterilization Wrap. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Medicom Group, Inc. (Pointe-Claire, CA). The FDA issued a Cleared decision on June 21, 2024 after a review of 85 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 Medicom Group, Inc. devices

Submission Details

510(k) Number K240862 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2024
Decision Date June 21, 2024
Days to Decision 85 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
44d faster than avg
Panel avg: 129d · This submission: 85d
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 100
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K240862.
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
Steriking® Pouch for Robotic Instruments
K232625 · Wipak OY · Jun 2024
PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)
K233777 · Primed Medical Products, Inc. · May 2024
Dukal SMS Sterilization Wrap
K233262 · Dukal, LLC · Mar 2024