Cleared Traditional

K252812 - UniPearls Embolic Microspheres

K252812 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 330-day FDA review.

K252812 · Suzhou Haowei Medical Technology Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
330d
Days
Class 2
Risk

K252812 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 July 31, 2026 after a review of 330 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K252812

510(k) Number K252812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2025
Decision Date July 31, 2026
Days to Decision 330 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
200d slower than avg
Panel avg: 130d · This submission: 330d
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 98
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K252812.
OBSIDIO Conformable Embolic
K261488 · Boston Scientific Corporation · Jul 2026
Concerto Versa™ Detachable Coil
K261866 · Medtronic, Inc. · Jun 2026
LOBO Vascular Occlusion System
K260508 · Okami Medical, Inc. · Apr 2026
Concerto Versa™ Detachable Coil
K253511 · Medtronic, Inc. · Jan 2026
Tembo Embolic System
K253677 · Instylla, Inc. · Dec 2025
OBSIDIO™ Conformable Embolic (M0013972101010)
K253376 · Boston Scientific Corporation · Oct 2025