Cleared Traditional

iMask Disposable Surgical Face Mask (K201182) - FDA 510(k) Clearance

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

K201182 · Pac-Dent, Inc. · General Hospital
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Feb 2021
Decision
294d
Days
Class 2
Risk

K201182 is an FDA 510(k) clearance for the iMask Disposable Surgical Face Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Pac-Dent, Inc. (Brea, US). The FDA issued a Cleared decision on February 19, 2021 after a review of 294 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 Pac-Dent, Inc. devices

Submission Details

510(k) Number K201182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2020
Decision Date February 19, 2021
Days to Decision 294 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
165d slower than avg
Panel avg: 129d · This submission: 294d
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 404
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K201182.
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
Phyziofit Medical Surgical Mask
K201868 · Wellpower Sporting Goods Co., Ltd. · 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
Surgical Face Mask
K201545 · Amphastar Nanjing Pharmaceuticals, Inc. · Feb 2021