Cleared Traditional

Phyziofit Medical Surgical Mask (K201868) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K201868 · Wellpower Sporting Goods Co., Ltd. · General Hospital
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Optimized for regulatory review, auditing and printing
Feb 2021
Decision
230d
Days
Class 2
Risk

K201868 is an FDA 510(k) clearance for the Phyziofit Medical Surgical Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Wellpower Sporting Goods Co., Ltd. (Dongguan, CN). The FDA issued a Cleared decision on February 22, 2021 after a review of 230 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 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. Standard predicate reliance. 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 Wellpower Sporting Goods Co., Ltd. devices

Submission Details

510(k) Number K201868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2020
Decision Date February 22, 2021
Days to Decision 230 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
101d slower than avg
Panel avg: 129d · This submission: 230d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 405
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K201868.
IFM Surgical Mask Model SM3
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Disposable Surgical Mask/Fluid Resistant Procedure Mask
K202240 · Lhm Medical Technology (Hong Kong) Limited · Feb 2021
Surgical Masks
K203524 · Bain Medical Equipment (Guangzhou) Co., Ltd. · Feb 2021
iMask Disposable Surgical Face Mask
K201182 · Pac-Dent, Inc. · Feb 2021
Surgical Face Mask (non-sterile)
K203426 · Nantong Taiweishi Medical Technology Co., Ltd. · Feb 2021
Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On
K201732 · Dukal Corporation · Feb 2021