Cleared Traditional

K192374 - Cardinal Health Level 3 Surgical Mask w...

K192374 is the FDA 510(k) clearance for Cardinal Health Level 3 Surgical Mask w... by Cardinal Health200, LLC. It is a Class 2 General Hospital device (product code FXX) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K192374 · Cardinal Health200, LLC · General Hospital
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Dec 2019
Decision
94d
Days
Class 2
Risk

K192374 is an FDA 510(k) clearance for the Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip. 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 December 2, 2019 after a review of 94 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

Submission Details

510(k) Number K192374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2019
Decision Date December 02, 2019
Days to Decision 94 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
35d faster than avg
Panel avg: 129d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 433
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K192374.
DemeMASK
K201479 · Demetech Corporation · Jul 2020
Surgical Face Mask
K200847 · Mexpo International, Inc. · Apr 2020
ClearMask Transparent Surgical Face Mask
K200576 · Clearmask, LLC · Apr 2020
3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask
K191355 · 3M Healthcare · Sep 2019
Surgical Face Mask
K182515 · Wuhan Dymex Healthcare Co., Ltd. · May 2019
Surgical Face Mask
K182514 · Xiantao Zhibo Non-Woven Products Co., Ltd. · Jan 2019