Cleared Traditional

K063043 - SURGICAL FACE MASK

K063043 is the FDA 510(k) clearance for SURGICAL FACE MASK by Modern Healthcare Corp.. It is a Class 2 General Hospital device (product code FXX) cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K063043 · Modern Healthcare Corp. · General Hospital
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Optimized for regulatory review, auditing and printing
Mar 2007
Decision
169d
Days
Class 2
Risk

K063043 is an FDA 510(k) clearance for the SURGICAL FACE MASK, TYPE: TIE-ON, EAR-LOOP. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Modern Healthcare Corp. (Hsin-Chu City, TW). The FDA issued a Cleared decision on March 21, 2007 after a review of 169 days - an extended review cycle.

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 Modern Healthcare Corp. devices

Submission Details

510(k) Number K063043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2006
Decision Date March 21, 2007
Days to Decision 169 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
40d slower than avg
Panel avg: 129d · This submission: 169d
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 434
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K063043.
Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties))
K173062 · V&Q Manufacturing Corporation · Jan 2018
KC 300 SURGICAL MASK
K131879 · Kimberly-Clark Corp. · Dec 2013
KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKS
K110455 · Kimberly-Clark Corp. · Apr 2011
MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD
K991559 · Medline Industries, Inc. · Aug 1999
DEPUY OPTI-CON AND E-Z SHIELD SYSTEMS
K964114 · Depuy, Inc. · May 1997
MEDLINE ADMISSION KITS
K965107 · Medline Industries, Inc. · Mar 1997