Cleared Abbreviated

K143287 - Fluidshield* Surgical Mask with Expande...

K143287 is an FDA 510(k) clearance for Fluidshield* Surgical Mask with Expande..., manufactured by Halyard Health, Inc.. The device is a Class 2 General Hospital device with product code FXX cleared through the Abbreviated 510(k) pathway after a 127-day FDA review.

K143287 · Halyard Health, Inc. · General Hospital
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Mar 2015
Decision
127d
Days
Class 2
Risk

K143287 is an FDA 510(k) clearance for the Fluidshield* Surgical Mask with Expanded Chamber. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Halyard Health, Inc. (Alpharetta, US). The FDA issued a Cleared decision on March 24, 2015 after a review of 127 days - within the typical 510(k) review window.

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.

View all Halyard Health, Inc. devices

FDA 510(k) Submission Details - K143287

510(k) Number K143287 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2014
Decision Date March 24, 2015
Days to Decision 127 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 129d · This submission: 127d
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 445
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K143287.
3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield
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K131879 · Kimberly-Clark Corp. · Dec 2013