Cleared Traditional

ADI Medical Surgical Face Mask (K213347) - FDA 510(k) Clearance

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

K213347 · Asia Dynamics Inc., D/B/A Adi Medical · General Hospital
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Jan 2022
Decision
109d
Days
Class 2
Risk

K213347 is an FDA 510(k) clearance for the ADI Medical Surgical Face Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Asia Dynamics Inc., D/B/A Adi Medical (Waukegan, US). The FDA issued a Cleared decision on January 25, 2022 after a review of 109 days - within the typical 510(k) review window.

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 Asia Dynamics Inc., D/B/A Adi Medical devices

Submission Details

510(k) Number K213347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 2021
Decision Date January 25, 2022
Days to Decision 109 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
20d faster than avg
Panel avg: 129d · This submission: 109d
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

Mdi Consultants, Inc.
Timothy Kania

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 405
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K213347.
Surgical Masks
K212120 · Hubei Xinxin Non-Woven Co., Ltd. · Jan 2022
American-Made Surgical Mask
K210101 · Armbrust, Inc. · Jan 2022
Surgical Face Mask
K212610 · Foshan Nanhai Plus Medical Co, Ltd. · Jan 2022
Myflon Surgical Mask Level 3
K212111 · Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi · Jan 2022
D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply
K213970 · Danameco Medical Joint Stock Corporation · Jan 2022
Surgical Face Mask
K203161 · Wuhan Raytex Protection Co., Ltd. · Jan 2022