Cleared Traditional

EmboCube Embolization Gelatin (K181021) - FDA 510(k) Clearance

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

K181021 · Biosphere Medical, S.A. · Cardiovascular device
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Sep 2018
Decision
163d
Days
Class 2
Risk

K181021 is an FDA 510(k) clearance for the EmboCube Embolization Gelatin. 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 27, 2018 after a review of 163 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3300 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Biosphere Medical, S.A. devices

Submission Details

510(k) Number K181021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2018
Decision Date September 27, 2018
Days to Decision 163 days
Submission Type Traditional
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
38d slower than avg
Panel avg: 125d · This submission: 163d
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - KRD Device, Vascular, For Promoting Embolization

All 70
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K181021.
Torpedo Gelatin Foam
K183578 · Biosphere Medical, S.A. · Jun 2019
IMPEDE-FX Embolization Plug
K182390 · Shape Memory Medical · May 2019
Dr. Amplatz Micro Plug
K182944 · Ka Medical, LLC · Apr 2019
Embosphere Microspheres
K181300 · Biosphere Medical, S.A. · Jul 2018
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