Cleared Abbreviated

K111402 - KC200, SURGICAL MASK, KC200, PROCEDURE MASK, KC300, SURGICALMASK, FLUIDSHIELD, KC300, PROCEDURE MASK, FLUIDSHIELD MODEL

K111402 is an FDA 510(k) clearance for KC200, manufactured by Kimberly-Clark. The device is a Class 2 General Hospital device with product code FXX cleared through the Abbreviated 510(k) pathway after a 154-day FDA review.

K111402 · Kimberly-Clark · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2011
Decision
154d
Days
Class 2
Risk

K111402 is an FDA 510(k) clearance for the KC200, SURGICAL MASK, KC200, PROCEDURE MASK, KC300, SURGICALMASK, FLUIDSHIELD.... Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Kimberly-Clark (Roswell, US). The FDA issued a Cleared decision on October 20, 2011 after a review of 154 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K111402

510(k) Number K111402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2011
Decision Date October 20, 2011
Days to Decision 154 days
Submission Type Abbreviated
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
25d slower than avg
Panel avg: 129d · This submission: 154d
Pathway characteristics
Standards-based clearance path.

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 K111402.
GREENCROSS SURGICAL MASK
K123787 · Jingzhou Haixin Green Cross Medical Products Co.,L · Jul 2013
ACME SURGICAL FACE MASK WITH EAR-LOOP MODEL YN-501 AB/W/G/P
K123115 · Acme Filter Mask, Inc. · May 2013
FACE MASK, SURGICAL MASK, PROCEDURE MASK, SURGICAL FACE MASK
K122717 · Tiger Medical Products, Ltd. · Dec 2012
CROSSTEX ISOFLUID PLUS SURGICAL EARLOOP MASK-BLUE, CROSSTEX ISOFLUID PLUS FOGFREE SURGICAL EARLOOP FACE MASK-BLUE, CROSS
K111343 · Crosstex International, Inc. · Oct 2011
SURGICAL MASKS
K111559 · Shanghai Neo-Medical Import & Export Co., Ltd. · Sep 2011
SURGICAL FACE MASK
K110027 · Angeline Group , Ltd. · Aug 2011
K111402 · KC200, SURGICAL MASK, KC200, PROCEDURE MASK, KC300, SURGICALMASK, FLUIDSHIELD, KC300, PROCEDURE MASK, FLUIDSHIELD MODEL
Download PDF FDA Summary Kimberly-Clark