Cleared Special

K242507 - OBSIDIO Conformable Embolic

K242507 is the FDA 510(k) clearance for OBSIDIO Conformable Embolic by Boston Scientific. It is a Class 2 Cardiovascular device (product code KRD) cleared through the Special 510(k) pathway after a 42-day FDA review.

K242507 · Boston Scientific · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2024
Decision
42d
Days
Class 2
Risk

K242507 is an FDA 510(k) clearance for the OBSIDIO™ Conformable Embolic. Classified as Device, Vascular, For Promoting Embolization (product code KRD), Class II - Special Controls.

Submitted by Boston Scientific (Maple Grove, US). The FDA issued a Cleared decision on October 3, 2024 after a review of 42 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.

View all Boston Scientific devices

Submission Details

510(k) Number K242507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2024
Decision Date October 03, 2024
Days to Decision 42 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
83d faster than avg
Panel avg: 125d · This submission: 42d
Pathway characteristics
Modification to existing cleared device.

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 97
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K242507.
Embozene Color-Advanced Microspheres
K242608 · Varian Medical Systems, Inc. · Jan 2025
TEMBO Embolic System
K240873 · Instylla, Inc. · Dec 2024
ONCOZENE Microspheres
K242794 · Varian Medical Systems, Inc. · 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
Easi-Vue® embolic microspheres System
K234123 · Abk Biomedical, Inc. · Feb 2024