Cleared Traditional

Eclipse 2L (K183045) - FDA 510(k) Clearance

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

K183045 · Balt USA, LLC · Neurology device
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Optimized for regulatory review, auditing and printing
Apr 2019
Decision
179d
Days
Class 2
Risk

K183045 is an FDA 510(k) clearance for the Eclipse 2L. Classified as Catheter, Intravascular Occluding, Temporary (product code MJN), Class II - Special Controls.

Submitted by Balt USA, LLC (Irvine, US). The FDA issued a Cleared decision on April 30, 2019 after a review of 179 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.4450 - the FDA neurology device 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Balt USA, LLC devices

Submission Details

510(k) Number K183045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2018
Decision Date April 30, 2019
Days to Decision 179 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 148d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MJN Catheter, Intravascular Occluding, Temporary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
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 Neurology devices follow this clearance model.

Regulatory Peers - MJN Catheter, Intravascular Occluding, Temporary

All 24
Devices cleared under the same product code (MJN) and FDA review panel - the closest regulatory comparables to K183045.
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Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr
K182916 · Lemaitre Vascular · Nov 2018
Sniper Infusion Catheter with Balloon Occlusion
K180904 · Embolx, Inc. · Jun 2018