Cleared Traditional

K182944 - Dr. Amplatz Micro Plug

K182944 is the FDA 510(k) clearance for Dr. Amplatz Micro Plug by Ka Medical, LLC. It is a Class 2 Cardiovascular device (product code KRD) cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K182944 · Ka Medical, LLC · Cardiovascular device
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Apr 2019
Decision
176d
Days
Class 2
Risk

K182944 is an FDA 510(k) clearance for the Dr. Amplatz Micro Plug. Classified as Device, Vascular, For Promoting Embolization (product code KRD), Class II - Special Controls.

Submitted by Ka Medical, LLC (Roseville, US). The FDA issued a Cleared decision on April 17, 2019 after a review of 176 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 Ka Medical, LLC devices

Submission Details

510(k) Number K182944 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2018
Decision Date April 17, 2019
Days to Decision 176 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
51d slower than avg
Panel avg: 125d · This submission: 176d
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 97
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K182944.
EmboCube Embolization Gelatin
K183120 · Biosphere Medical, S.A. · Aug 2019
Torpedo Gelatin Foam
K183578 · Biosphere Medical, S.A. · Jun 2019
IMPEDE-FX Embolization Plug
K182390 · Shape Memory Medical · May 2019
EmboCube Embolization Gelatin
K181021 · Biosphere Medical, S.A. · Sep 2018
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