Cleared Traditional

K182390 - IMPEDE-FX Embolization Plug (FDA 510(k) Clearance)

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

K182390 · Shape Memory Medical · Cardiovascular device
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.

Submission Details

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
Regulatory Context
Review time vs. panel average
121d slower than avg
Panel avg: 140d · This submission: 261d
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 17
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K182390.
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K253376 · Boston Scientific Corporation · Oct 2025
Polyvinyl Alcohol Embolic Microspheres
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Prestige Coil System (Prestige Packing Line Extension)
K251383 · Balt USA, LLC · May 2025