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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 605
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K063043.
CROSSTEX ISOLITE AND ISOFLUID EARLOOP FACE MASKS AND ISOFLUID FOGFREE FACE MASKS WITH AND WITHOUT SPLASH VISOR
K082258 · Crosstex International · Oct 2008
PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS
K081633 · Primed Medical Products, Inc. · Aug 2008
DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHITE
K070407 · Dukal Corp. · Mar 2007
DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530
K061864 · Dukal Corp. · Sep 2006
PRESTIGE AMERITECH FACE MASK
K061716 · Prestige Ameritech · Aug 2006
SURGICAL FACE MASK
K060776 · Hong YA Non-Woven Products Co., Ltd. · May 2006
K063043 · SURGICAL FACE MASK, TYPE: TIE-ON, EAR-LOOP
Download PDF FDA Summary Modern Healthcare Cor…