Cleared Traditional

Sheng Jing Tang Surgical Mask (K211260) - FDA 510(k) Clearance

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

K211260 · Liaoning Shengjingtang Biotechnology Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2022
Decision
259d
Days
Class 2
Risk

K211260 is an FDA 510(k) clearance for the Sheng Jing Tang Surgical Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Liaoning Shengjingtang Biotechnology Co., Ltd. (Shenyang, CN). The FDA issued a Cleared decision on January 10, 2022 after a review of 259 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 Liaoning Shengjingtang Biotechnology Co., Ltd. devices

Submission Details

510(k) Number K211260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2021
Decision Date January 10, 2022
Days to Decision 259 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
130d slower than avg
Panel avg: 129d · This submission: 259d
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

Huamei (Dalian) Health Industry Co., Ltd.
Hai Luan

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 K211260.
Kangbeier Surgical Mask (Model: KBR-1001)
K213920 · Xinxiang Kangbeier Medical Technology Co., Ltd. · Jan 2022
Surgical Face Mask
K212913 · Jiangxi Ganlong Pharmaceutical Co., Ltd. · Jan 2022
Surgical Mask
K212997 · Guangdong Zhizhen Biological Medical Co., Ltd. · Jan 2022
Medical Surgical Mask
K212299 · Wepon Medical Technology Co., Ltd. · Jan 2022
Disposable Medical Surgical Mask
K212375 · Jiangxi Bestgrand Health Technology Co., Ltd. · Jan 2022
Skypro, SP02 Mask (3)
K202255 · Skypro Medical Supplies Company · Dec 2021