Cleared Traditional

K210321 - Dukal Corporation Level 1 Pediatric Face Mask (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
290d slower than avg
Panel avg: 128d · 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

All 8
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