Cleared Traditional

K123115 - ACME SURGICAL FACE MASK WITH EAR-LOOP MODEL YN-501 AB/W/G/P

K123115 is an FDA 510(k) clearance for ACME SURGICAL FACE MASK WITH EAR-LOOP M..., manufactured by Acme Filter Mask, Inc.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 229-day FDA review.

K123115 · Acme Filter Mask, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
229d
Days
Class 2
Risk

K123115 is an FDA 510(k) clearance for the ACME SURGICAL FACE MASK WITH EAR-LOOP MODEL YN-501 AB/W/G/P. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Acme Filter Mask, Inc. (New Taipei City, TW). The FDA issued a Cleared decision on May 20, 2013 after a review of 229 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 - K123115

510(k) Number K123115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2012
Decision Date May 20, 2013
Days to Decision 229 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
100d slower than avg
Panel avg: 129d · This submission: 229d
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 557
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K123115.
SECURE-GARD SURGICAL AND PROCEDURE FACE MASK
K140155 · Cardinal Health200, LLC · Jun 2014
KC 300 SURGICAL MASK
K131879 · Kimberly-Clark Corp. · Dec 2013
GREENCROSS SURGICAL MASK
K123787 · Jingzhou Haixin Green Cross Medical Products Co.,L · Jul 2013
FACE MASK, SURGICAL MASK, PROCEDURE MASK, SURGICAL FACE MASK
K122717 · Tiger Medical Products, Ltd. · Dec 2012
KC200, SURGICAL MASK, KC200, PROCEDURE MASK, KC300, SURGICALMASK, FLUIDSHIELD, KC300, PROCEDURE MASK, FLUIDSHIELD MODEL
K111402 · Kimberly-Clark · Oct 2011
CROSSTEX ISOFLUID PLUS SURGICAL EARLOOP MASK-BLUE, CROSSTEX ISOFLUID PLUS FOGFREE SURGICAL EARLOOP FACE MASK-BLUE, CROSS
K111343 · Crosstex International, Inc. · Oct 2011
K123115 · ACME SURGICAL FACE MASK WITH EAR-LOOP MODEL YN-501 AB/W/G/P
Download PDF FDA Summary Acme Filter Mask, Inc.