Cleared Traditional

K220920 - Matreneu Percutaneous Balloon Compression Kit (FDA 510(k) Clearance)

Class I Neurology device.

K220920 · Shenzhen Shineyard Medical Device Co. , Ltd. · Neurology device
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Sep 2022
Decision
161d
Days
Class 1
Risk

K220920 is an FDA 510(k) clearance for the Matreneu Percutaneous Balloon Compression Kit. Classified as Instrument, Surgical, Non-powered (product code HAO), Class I - General Controls.

Submitted by Shenzhen Shineyard Medical Device Co. , Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on September 7, 2022 after a review of 161 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4535 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Shenzhen Shineyard Medical Device Co. , Ltd. devices

Submission Details

510(k) Number K220920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2022
Decision Date September 07, 2022
Days to Decision 161 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 148d · This submission: 161d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HAO Instrument, Surgical, Non-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 882.4535
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

Shenzhen Joyantech Consulting Co., Ltd.
Joyce Yang

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.