Cleared Abbreviated

K101000 - WELLMIEN SURGICAL MASK

K101000 is an FDA 510(k) clearance for WELLMIEN SURGICAL MASK, manufactured by Wellmien (Suzhou) Import & Export Trading Co., Ltd.. The device is a Class 2 General Hospital device with product code FXX cleared through the Abbreviated 510(k) pathway after a 119-day FDA review.

K101000 · Wellmien (Suzhou) Import & Export Trading Co., Ltd. · General Hospital
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Aug 2010
Decision
119d
Days
Class 2
Risk

K101000 is an FDA 510(k) clearance for the WELLMIEN SURGICAL MASK. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Wellmien (Suzhou) Import & Export Trading Co., Ltd. (Pennington, US). The FDA issued a Cleared decision on August 9, 2010 after a review of 119 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.

FDA 510(k) Submission Details - K101000

510(k) Number K101000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2010
Decision Date August 09, 2010
Days to Decision 119 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 129d · This submission: 119d
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 601
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K101000.
CROSSTEX SURGICAL EARLOOP MASK- WHITE, CROSSTEX SURGICAL EARLOOP NO FOG MASK-WHITE, NO FOG MASK WITH SPLASH VISOR-WHITE
K103303 · Crosstex International, Inc. · Dec 2010
SURGICAL FACE MASK
K093901 · Epard Protective Products, Ltd. · Sep 2010
IMC SURGICAL FACE MASK
K100846 · International Medsurg Connection · Aug 2010
MEDICAL SURGICAL MASK (HH1001), RESPIRATORY MASK (HH1002)
K093179 · H&H Research Company · Jul 2010
TIDI FACEMASK
K100800 · Tidi Products,Llc · Jun 2010
TIDI FACEMASK
K092580 · Tidi Products,Llc · Feb 2010
K101000 · WELLMIEN SURGICAL MASK
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