Cleared Traditional

CiRx (R) Surgical Mask (K210256) - FDA 510(k) Clearance

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

K210256 · Ningbo Shun YE Medical Company, Ltd. · General Hospital
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Aug 2021
Decision
199d
Days
Class 2
Risk

K210256 is an FDA 510(k) clearance for the CiRx (R) Surgical Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Ningbo Shun YE Medical Company, Ltd. (Ningbo, CN). The FDA issued a Cleared decision on August 19, 2021 after a review of 199 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 Ningbo Shun YE Medical Company, Ltd. devices

Submission Details

510(k) Number K210256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2021
Decision Date August 19, 2021
Days to Decision 199 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
70d slower than avg
Panel avg: 129d · This submission: 199d
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 K210256.
Surgical mask
K202746 · Ningbo Jingeao Electronics, Inc. · Aug 2021
Disposable Surgical Mask (non sterile)
K211451 · Qinhuangdao Taizhi Medical Technology Co., Ltd. · Aug 2021
Disposable medical face mask
K202745 · Ningbo Jingeao Electronics, Inc. · Aug 2021
ECOMA Level 2 Disposable Surgical Mask with Ear Loops
K210698 · Xianning Eco Medical Articles Co., Ltd. · Aug 2021
Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3
K211066 · Homtex, Inc. · Aug 2021
Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask
K211462 · Xiantao S&J Protective Products Co., Ltd. · Aug 2021