Cleared Traditional

K242608 - Embozene Color-Advanced Microspheres (FDA 510(k) Clearance)

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

K242608 · Varian Medical Systems, Inc. · Gastroenterology & Urology device
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Jan 2025
Decision
136d
Days
Class 2
Risk

K242608 is an FDA 510(k) clearance for the Embozene Color-Advanced Microspheres. Classified as Device, Vascular, For Promoting Embolization (product code KRD), Class II - Special Controls.

Submitted by Varian Medical Systems, Inc. (Palo Alto, US). The FDA issued a Cleared decision on January 17, 2025 after a review of 136 days - within the typical 510(k) review window.

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 Varian Medical Systems, Inc. devices

Submission Details

510(k) Number K242608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2024
Decision Date January 17, 2025
Days to Decision 136 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
6d slower than avg
Panel avg: 130d · This submission: 136d
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 127
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K242608.
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
Polyvinyl Alcohol Embolic Microspheres
K250209 · Canyon Medical, Inc. · Sep 2025
HARBOR Occlusion Device
K250133 · Nuvascular, Inc. · Jul 2025