Cleared Traditional

K240330 - HALYARD* SMART-FOLD* Sterilization Wrap...

Also marketed or referenced as:
HALYARD* SMART-FOLD* Sterilization Wrap (H650)

K240330 is the FDA 510(k) clearance for HALYARD* SMART-FOLD* Sterilization Wrap... by O&M Halyard, Inc.. It is a Class 2 General Hospital device (product code FRG) cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K240330 · O&M Halyard, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2024
Decision
184d
Days
Class 2
Risk

K240330 is an FDA 510(k) clearance for the HALYARD* SMART-FOLD* Sterilization Wrap (H450). Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by O&M Halyard, Inc. (Mechanicsville, US). The FDA issued a Cleared decision on August 7, 2024 after a review of 184 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 O&M Halyard, Inc. devices

Submission Details

510(k) Number K240330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2024
Decision Date August 07, 2024
Days to Decision 184 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
55d slower than avg
Panel avg: 129d · This submission: 184d
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 118
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K240330.
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
Medicom Sterilization Wrap
K240862 · Medicom Group, Inc. · Jun 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