Cleared Special

K242794 - ONCOZENE Microspheres

K242794 is an FDA 510(k) clearance for ONCOZENE Microspheres, manufactured by Varian Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code KRD cleared through the Special 510(k) pathway after a 30-day FDA review.

K242794 · Varian Medical Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2024
Decision
30d
Days
Class 2
Risk

K242794 is an FDA 510(k) clearance for the ONCOZENE 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 October 16, 2024 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K242794

510(k) Number K242794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2024
Decision Date October 16, 2024
Days to Decision 30 days
Submission Type Special
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
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 Cardiovascular devices follow this clearance model.

Regulatory Peers - KRD Device, Vascular, For Promoting Embolization

All 132
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K242794.
Ruby XL System
K250079 · Penumbra, Inc. · Mar 2025
Embozene Color-Advanced Microspheres
K242608 · Varian Medical Systems, Inc. · Jan 2025
TEMBO Embolic System
K240873 · Instylla, Inc. · Dec 2024
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
K242794 · ONCOZENE Microspheres
Download PDF FDA Summary Varian Medical System…