Cleared Traditional

Disposable medical surgical mask (K212097) - FDA 510(k) Clearance

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

K212097 · Hebei Titans Hongsen Medical Technology Co., Ltd. · General Hospital
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Optimized for regulatory review, auditing and printing
Aug 2021
Decision
43d
Days
Class 2
Risk

K212097 is an FDA 510(k) clearance for the Disposable medical surgical mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Hebei Titans Hongsen Medical Technology Co., Ltd. (Xingtai, CN). The FDA issued a Cleared decision on August 18, 2021 after a review of 43 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hebei Titans Hongsen Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K212097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2021
Decision Date August 18, 2021
Days to Decision 43 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
86d faster than avg
Panel avg: 129d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

Beijing Believe-Med Technology Service Co., Ltd.
Ray Wang

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 - FXX Mask, Surgical

All 404
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K212097.
WYZ Surgical Mask
K211576 · Wyz Medical Supplies, LLC · Aug 2021
Surgical mask
K211454 · Jiangsu Xingtong Biotechnology Group Co., Ltd. · Aug 2021
Surgical Face Mask
K211631 · Macheng Thimble Technology Investment Co., Ltd. · Aug 2021
Disposable Face Mask
K203152 · Chaozhou Cecilia Technology Co., Ltd. · Aug 2021
Medical Face Mask
K211353 · Shenzhen Lyttop Healthcare Limited · Aug 2021
Surgical mask
K211552 · Shandong Shengquan New Materials Co., Ltd. · Aug 2021