Cleared Special

QuadraSphere Microspheres (K172372) - FDA 510(k) Clearance

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K172372 · Biosphere Medical, S.A. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2017
Decision
30d
Days
Class 2
Risk

K172372 is an FDA 510(k) clearance for the QuadraSphere Microspheres. Classified as Device, Vascular, For Promoting Embolization (product code KRD), Class II - Special Controls.

Submitted by Biosphere Medical, S.A. (Roissy-En-France, FR). The FDA issued a Cleared decision on September 6, 2017 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.3300 - the FDA neurology device 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 Biosphere Medical, S.A. devices

Submission Details

510(k) Number K172372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2017
Decision Date September 06, 2017
Days to Decision 30 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 148d · This submission: 30d
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 Neurology devices follow this clearance model.

Regulatory Peers - KRD Device, Vascular, For Promoting Embolization

All 71
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K172372.
IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm
K181051 · Shape Memory Medical · Jun 2018
Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume
K173891 · Vascular Solutions, Inc. · Jan 2018
Gel-Bead
K171946 · Vascular Solutions, Inc. · Oct 2017
AZUR CX Detachable 18 Peripheral Coil System
K162524 · MicroVention, Inc. · Mar 2017
Hilal Embolization MicroCoils
K160219 · Cook Incorporated · Aug 2016
Nester Embolization Coils, Tornado Embolization Coils
K153778 · Cook Incorporated · May 2016