Cleared Traditional

UniPearls® Embolic Microspheres (K231554) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K231554 · Suzhou Haowei Medical Technology Co., Ltd. · Gastroenterology & Urology device
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Nov 2023
Decision
168d
Days
Class 2
Risk

K231554 is an FDA 510(k) clearance for the UniPearls® Embolic Microspheres. Classified as Device, Vascular, For Promoting Embolization (product code KRD), Class II - Special Controls.

Submitted by Suzhou Haowei Medical Technology Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on November 14, 2023 after a review of 168 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 870.3300 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Suzhou Haowei Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K231554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2023
Decision Date November 14, 2023
Days to Decision 168 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 130d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KRD Device, Vascular, For Promoting Embolization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3300
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KRD Device, Vascular, For Promoting Embolization

All 70
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K231554.
Sunsphere
K232934 · Hangzhou Yangshun Medical Technology Co.,Ltd · May 2024
Siege Vascular Plug (SVP2.5-0.021)
K240261 · Merit Medical Systems, Inc. · May 2024
Easi-Vue® embolic microspheres System
K234123 · Abk Biomedical, Inc. · Feb 2024
EMBOLD™ Soft Detachable Coil System
K230706 · Boston Scientific Corporation · Jun 2023
AZUR HydroPack 18 (45-880005
K223050 · MicroVention, Inc. · Dec 2022
Easi-Vue embolic microspheres System
K220567 · Abk Biomedical, Inc. · Sep 2022