Cleared Traditional

K140155 - SECURE-GARD SURGICAL AND PROCEDURE FACE MASK

K140155 is an FDA 510(k) clearance for SECURE-GARD SURGICAL AND PROCEDURE FACE..., manufactured by Cardinal Health200, LLC. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K140155 · Cardinal Health200, LLC · General Hospital
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Jun 2014
Decision
149d
Days
Class 2
Risk

K140155 is an FDA 510(k) clearance for the SECURE-GARD SURGICAL AND PROCEDURE FACE MASK. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Cardinal Health200, LLC (Waukegan, US). The FDA issued a Cleared decision on June 20, 2014 after a review of 149 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - 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 Cardinal Health200, LLC devices

FDA 510(k) Submission Details - K140155

510(k) Number K140155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2014
Decision Date June 20, 2014
Days to Decision 149 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
20d slower than avg
Panel avg: 129d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FXX Device Classification - Class 2, Special Controls

Product Code FXX Mask, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
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 - FXX Mask, Surgical

All 500
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K140155.
WestTec Procedure Facemask
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Fluidshield* Surgical Mask with Expanded Chamber
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K123787 · Jingzhou Haixin Green Cross Medical Products Co.,L · Jul 2013
ACME SURGICAL FACE MASK WITH EAR-LOOP MODEL YN-501 AB/W/G/P
K123115 · Acme Filter Mask, Inc. · May 2013