Cleared Traditional

K141085 - WestTec Procedure Facemask

Also marketed or referenced as:
WestTec Surgical Facemask

K141085 is an FDA 510(k) clearance for WestTec Procedure Facemask, manufactured by Westtec, LLC. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 333-day FDA review.

K141085 · Westtec, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2015
Decision
333d
Days
Class 2
Risk

K141085 is an FDA 510(k) clearance for the WestTec Procedure Facemask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Westtec, LLC (Kaysville, US). The FDA issued a Cleared decision on March 27, 2015 after a review of 333 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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.

View all Westtec, LLC devices

FDA 510(k) Submission Details - K141085

510(k) Number K141085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2014
Decision Date March 27, 2015
Days to Decision 333 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
204d slower than avg
Panel avg: 129d · This submission: 333d
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 456
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K141085.
3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield
K180874 · 3M Healthcare · Jul 2018
Technoweb Surgical Mask
K172500 · Yts Global, Inc. · Mar 2018
Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties))
K173062 · V&Q Manufacturing Corporation · Jan 2018
Insta-Gard Surgical and Procedure Face Mask
K142990 · Cardinal Health200, LLC · Mar 2015
SECURE-GARD SURGICAL AND PROCEDURE FACE MASK
K140155 · Cardinal Health200, LLC · Jun 2014
KC 300 SURGICAL MASK
K131879 · Kimberly-Clark Corp. · Dec 2013