Cleared Traditional

K242608 - Embozene Color-Advanced Microspheres

K242608 is the FDA 510(k) clearance for Embozene Color-Advanced Microspheres by Varian Medical Systems, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KRD) cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K242608 · Varian Medical Systems, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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 97
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K242608.
Embosphere Microspheres
K250971 · Biosphere Medical, S.A. · May 2025
Nitinol Enhanced Device (NED)
K250276 · Embolization, Inc. · May 2025
Ruby XL System
K250079 · Penumbra, Inc. · Mar 2025
TEMBO Embolic System
K240873 · Instylla, Inc. · Dec 2024
ONCOZENE Microspheres
K242794 · Varian Medical Systems, Inc. · Oct 2024
OBSIDIO™ Conformable Embolic
K242507 · Boston Scientific · Oct 2024