Cleared Traditional

K220520 - PM Excellence SEQUR 100 Surgical Face Mask

K220520 is an FDA 510(k) clearance for PM Excellence SEQUR 100 Surgical Face Mask, manufactured by Pm Excellence, LLC. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 295-day FDA review.

K220520 · Pm Excellence, LLC · General Hospital
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Dec 2022
Decision
295d
Days
Class 2
Risk

K220520 is an FDA 510(k) clearance for the PM Excellence SEQUR 100 Surgical Face Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Pm Excellence, LLC (Bellmore, US). The FDA issued a Cleared decision on December 15, 2022 after a review of 295 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 Pm Excellence, LLC devices

FDA 510(k) Submission Details - K220520

510(k) Number K220520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2022
Decision Date December 15, 2022
Days to Decision 295 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
166d slower than avg
Panel avg: 129d · This submission: 295d
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 444
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K220520.
Surgical Face Mask
K222483 · Hubei Woozon Healthcare Co., Ltd. · Jan 2023
Medical Disposable Face Masks
K222809 · Anqing Mayfield Medical Limited · Jan 2023
Surgical Mask
K213601 · Wuhan Zonsen Medical Products Co., Ltd. · Dec 2022
Surgical Face Mask
K222651 · Xiantao Sanda Industrial Co., Ltd. · Dec 2022
3-Ply Disposable Medical Mask
K223045 · Wealth Lead Industrial Limited · Dec 2022
Disposable Medical Face Mask
K223055 · Xiantao Zhuobo Industrial Co., Ltd. · Dec 2022