Cleared Abbreviated

K143287 - Fluidshield* Surgical Mask with Expanded Chamber (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K143287 · Halyard Health, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
1d faster than avg
Panel avg: 128d · This submission: 127d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 606
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