Cleared Traditional

Disposable Surgical Mask (Model: YYKZ-01) (K210845) - FDA 510(k) Clearance

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

K210845 · Jiaxing Amazing Travel-Ware Co., Ltd. · General Hospital
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Oct 2021
Decision
204d
Days
Class 2
Risk

K210845 is an FDA 510(k) clearance for the Disposable Surgical Mask (Model: YYKZ-01). Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Jiaxing Amazing Travel-Ware Co., Ltd. (Jiaxing, CN). The FDA issued a Cleared decision on October 12, 2021 after a review of 204 days - an extended review 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: 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 Jiaxing Amazing Travel-Ware Co., Ltd. devices

Submission Details

510(k) Number K210845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2021
Decision Date October 12, 2021
Days to Decision 204 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
75d slower than avg
Panel avg: 129d · This submission: 204d
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 Peers - FXX Mask, Surgical

All 405
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K210845.
Surgical Face Mask
K212368 · Anhui Tiankang Medical Technology Co., Ltd. · Oct 2021
Surgical 3D Mask
K203565 · Inno Lifecare · Oct 2021
Medical Protective Masks
K212205 · Qinhuangdao Taizhi Medical Technology Co., Ltd. · Oct 2021
Single-Use Medical Face Mask
K210622 · Jiangxi Hongda Medical Equipment Group Co., Ltd. · Oct 2021
Medical Surgical Mask
K210813 · Sichuan Pharmaceutical., Inc. · Oct 2021
Private Stock Labs Surgical Face Mask
K211425 · J.K. Private Stock, Inc. · Oct 2021