Cleared Traditional

K182390 - IMPEDE-FX Embolization Plug

K182390 is an FDA 510(k) clearance for IMPEDE-FX Embolization Plug, manufactured by Shape Memory Medical. The device is a Class 2 Cardiovascular device with product code KRD cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K182390 · Shape Memory Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2019
Decision
261d
Days
Class 2
Risk

K182390 is an FDA 510(k) clearance for the IMPEDE-FX Embolization Plug. Classified as Device, Vascular, For Promoting Embolization (product code KRD), Class II - Special Controls.

Submitted by Shape Memory Medical (Santa Clara, US). The FDA issued a Cleared decision on May 23, 2019 after a review of 261 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 Shape Memory Medical devices

FDA 510(k) Submission Details - K182390

510(k) Number K182390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2018
Decision Date May 23, 2019
Days to Decision 261 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
136d slower than avg
Panel avg: 125d · This submission: 261d
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 119
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K182390.
Okami Medical LOBO Vascular Occlusion System
K192083 · Okami Medical · Oct 2019
EmboCube Embolization Gelatin
K183120 · Biosphere Medical, S.A. · Aug 2019
Torpedo Gelatin Foam
K183578 · Biosphere Medical, S.A. · Jun 2019
Dr. Amplatz Micro Plug
K182944 · Ka Medical, LLC · Apr 2019
EmboCube Embolization Gelatin
K181021 · Biosphere Medical, S.A. · Sep 2018
Embosphere Microspheres
K181300 · Biosphere Medical, S.A. · Jul 2018