Cleared Traditional

K231554 - UniPearls Embolic Microspheres

K231554 is an FDA 510(k) clearance for UniPearls Embolic Microspheres, manufactured by Suzhou Haowei Medical Technology Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code KRD cleared through the Traditional 510(k) pathway after a 168-day FDA review.

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

FDA 510(k) Submission Details - K231554

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.

KRD Device Classification - Class 2, Special Controls

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 97
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