Cleared Traditional

K183578 - Torpedo Gelatin Foam

K183578 is an FDA 510(k) clearance for Torpedo Gelatin Foam, manufactured by Biosphere Medical, S.A.. The device is a Class 2 Cardiovascular device with product code KRD cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K183578 · Biosphere Medical, S.A. · Cardiovascular device
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Jun 2019
Decision
179d
Days
Class 2
Risk

K183578 is an FDA 510(k) clearance for the Torpedo Gelatin Foam. 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 June 18, 2019 after a review of 179 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

FDA 510(k) Submission Details - K183578

510(k) Number K183578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2018
Decision Date June 18, 2019
Days to Decision 179 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
54d slower than avg
Panel avg: 125d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 97
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K183578.
Torpedo Gelatin Foam
K192480 · Biosphere Medical, S.A. · Nov 2019
Okami Medical LOBO Vascular Occlusion System
K192083 · Okami Medical · Oct 2019
EmboCube Embolization Gelatin
K183120 · Biosphere Medical, S.A. · Aug 2019
IMPEDE-FX Embolization Plug
K182390 · Shape Memory Medical · May 2019
Dr. Amplatz Micro Plug
K182944 · Ka Medical, LLC · Apr 2019
EmboCube Embolization Gelatin
K181021 · Biosphere Medical, S.A. · Sep 2018