Cleared Traditional

K201514 - Child Face Mask (FDA 510(k) Clearance)

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

K201514 · Shandong Shengquan New Material Co., Ltd. · General Hospital
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Oct 2021
Decision
489d
Days
Class 2
Risk

K201514 is an FDA 510(k) clearance for the Child Face Mask. Classified as Pediatric/child Facemask (product code OXZ), Class II - Special Controls.

Submitted by Shandong Shengquan New Material Co., Ltd. (Jinan, CN). The FDA issued a Cleared decision on October 10, 2021 after a review of 489 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 Shandong Shengquan New Material Co., Ltd. devices

Submission Details

510(k) Number K201514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2020
Decision Date October 10, 2021
Days to Decision 489 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
361d slower than avg
Panel avg: 128d · This submission: 489d
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 Consultant

Shanghai Landlink Medical Information Technology Co., Ltd.
Shelley Li

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K201514.
Kangbeier Child Surgical Mask
K221753 · Xinxiang Kangbeier Medical Technology Co., Ltd. · Dec 2023
PRIMED Pediatric Facemask
K213427 · Primed Medical Products, Inc. · Nov 2022
Dukal Corporation Level 1 Pediatric Face Mask
K210321 · Dukal Corporation · Mar 2022
The iMask Child's Face Mask
K202831 · Pac-Dent, Inc. · Aug 2021