Cleared Traditional

K201421 - Dukal Corporation Level 2 Surgical Mask...

Also marketed or referenced as:
Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield Dukal Corporation Level 2 Surgical Mask with Adjustable Tie Ons

K201421 is an FDA 510(k) clearance for Dukal Corporation Level 2 Surgical Mask..., 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 252-day FDA review.

K201421 · Dukal Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2021
Decision
252d
Days
Class 2
Risk

K201421 is an FDA 510(k) clearance for the Dukal Corporation Level 2 Surgical Mask with Ear Loops. 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 5, 2021 after a review of 252 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 - K201421

510(k) Number K201421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2020
Decision Date February 05, 2021
Days to Decision 252 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
123d slower than avg
Panel avg: 129d · This submission: 252d
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 K201421.
Disposable Surgical Mask
K202341 · Shanghai Jianzhong Medical Packaging Co., Ltd. · Feb 2021
Standard Procedure Mask, Standard Surgical Mask
K202605 · Jiangsu Medplus Non-Woven Manufacturer Co., Ltd. · Feb 2021
nPro Surgical Mask
K203265 · Np Medical, Inc. · Feb 2021
Freudenberg Surgical Mask
K210063 · Freudenberg Performance Materials LP · Feb 2021
Medical Face Mask
K202493 · Gemtier Medical (Shanghai), Inc. · Feb 2021
Medical Face Masks
K202627 · Guilin Hbm Sanitary Protections, Inc. · Feb 2021