Cleared Traditional

Dukal Corporation Level 1 Pediatric Face Mask (K210321) - FDA 510(k) Clearance

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

K210321 · Dukal Corporation · General Hospital
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Mar 2022
Decision
418d
Days
Class 2
Risk

K210321 is an FDA 510(k) clearance for the Dukal Corporation Level 1 Pediatric Face Mask. Classified as Pediatric/child Facemask (product code OXZ), Class II - Special Controls.

Submitted by Dukal Corporation (Ronkonkoma, US). The FDA issued a Cleared decision on March 29, 2022 after a review of 418 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Dukal Corporation devices

Submission Details

510(k) Number K210321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2021
Decision Date March 29, 2022
Days to Decision 418 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
289d slower than avg
Panel avg: 129d · This submission: 418d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OXZ Pediatric/child Facemask
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
Definition A Pediatric/child Facemask Is Intended To Be Worn By The Patient/child To Provide Protection For The Respiratory Tract. It Is A Single Use, Disposable Device That Is Provided Non-sterile. The Facemask Is Recommended For Use In A Healthcare Setting With Appropriate Adult Supervision.
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 - OXZ Pediatric/child Facemask

Devices cleared under the same product code (OXZ) and FDA review panel - the closest regulatory comparables to K210321.
Kangbeier Child Surgical Mask
K221753 · Xinxiang Kangbeier Medical Technology Co., Ltd. · Dec 2023
PRIMED Pediatric Facemask
K213427 · Primed Medical Products, Inc. · Nov 2022
Child Face Mask
K201514 · Shandong Shengquan New Material Co., Ltd. · Oct 2021
The iMask Child's Face Mask
K202831 · Pac-Dent, Inc. · Aug 2021
Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1)
K190308 · Amd Medicom, Inc. · Sep 2019