Cleared Traditional

K063043 - SURGICAL FACE MASK, TYPE: TIE-ON, EAR-LOOP

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

K063043 · Modern Healthcare Corp. · General Hospital
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K063043

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.

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 501
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K063043.
SURGICAL FACE MASK
K110027 · Angeline Group , Ltd. · Aug 2011
KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKS
K110455 · Kimberly-Clark Corp. · Apr 2011
CROSSTEX SURGICAL EARLOOP MASK- WHITE, CROSSTEX SURGICAL EARLOOP NO FOG MASK-WHITE, NO FOG MASK WITH SPLASH VISOR-WHITE
K103303 · Crosstex International, Inc. · Dec 2010
SURGICAL FACE MASK
K050689 · China Surgical Dressings Center Co., Ltd. · Oct 2005
NON-STERILE SURGICAL MASK
K051291 · A.R. Medicom, Inc. · Sep 2005
SURGICAL FACE MASK
K043199 · Hong YA Non-Woven Products Co., Ltd. · Feb 2005