Cleared Traditional

K201732 - Dukal Corporation Level 3 Surgical Face...

K201732 is an FDA 510(k) clearance for Dukal Corporation Level 3 Surgical Face..., manufactured by Dukal Corporation. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 236-day FDA review.

K201732 · Dukal Corporation · General Hospital
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Feb 2021
Decision
236d
Days
Class 2
Risk

K201732 is an FDA 510(k) clearance for the Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporatio.... Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Dukal Corporation (Ronkonkoma, US). The FDA issued a Cleared decision on February 16, 2021 after a review of 236 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 Dukal Corporation devices

FDA 510(k) Submission Details - K201732

510(k) Number K201732 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2020
Decision Date February 16, 2021
Days to Decision 236 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
107d slower than avg
Panel avg: 129d · This submission: 236d
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
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