Cleared Traditional

Easi-Vue® embolic microspheres System (K234123) - FDA 510(k) Clearance

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

K234123 · Abk Biomedical, Inc. · Cardiovascular device
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Feb 2024
Decision
47d
Days
Class 2
Risk

K234123 is an FDA 510(k) clearance for the Easi-Vue® embolic microspheres System. Classified as Device, Vascular, For Promoting Embolization (product code KRD), Class II - Special Controls.

Submitted by Abk Biomedical, Inc. (Halifax, CA). The FDA issued a Cleared decision on February 13, 2024 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3300 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Abk Biomedical, Inc. devices

Submission Details

510(k) Number K234123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2023
Decision Date February 13, 2024
Days to Decision 47 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 125d · This submission: 47d
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 Cardiovascular 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 K234123.
OBSIDIO™ Conformable Embolic
K242507 · Boston Scientific · Oct 2024
Sunsphere
K232934 · Hangzhou Yangshun Medical Technology Co.,Ltd · May 2024
Siege Vascular Plug (SVP2.5-0.021)
K240261 · Merit Medical Systems, Inc. · May 2024
UniPearls® Embolic Microspheres
K231554 · Suzhou Haowei Medical Technology Co., Ltd. · Nov 2023
EMBOLD™ Soft Detachable Coil System
K230706 · Boston Scientific Corporation · Jun 2023
AZUR HydroPack 18 (45-880005
K223050 · MicroVention, Inc. · Dec 2022