Cleared Traditional

Optima Coil System (K172390) - FDA 510(k) Clearance

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

K172390 · Blockade Medical, LLC (D.B.A. Balt Usa) · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2018
Decision
194d
Days
Class 2
Risk

K172390 is an FDA 510(k) clearance for the Optima Coil System. Classified as Device, Neurovascular Embolization (product code HCG), Class II - Special Controls.

Submitted by Blockade Medical, LLC (D.B.A. Balt Usa) (Irvine, US). The FDA issued a Cleared decision on February 18, 2018 after a review of 194 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5950 - 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 Blockade Medical, LLC (D.B.A. Balt Usa) devices

Submission Details

510(k) Number K172390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2017
Decision Date February 18, 2018
Days to Decision 194 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
46d slower than avg
Panel avg: 148d · This submission: 194d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HCG Device, Neurovascular Embolization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5950
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 - HCG Device, Neurovascular Embolization

All 47
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K172390.
Spartan eCoil System
K180653 · Spartan Micro, Inc. · Dec 2018
Wallaby Avenir Coil System
K173711 · Wallaby Medical, Inc. · May 2018
Penumbra Coil 400, Ruby Coil System, POD System
K173614 · Penumbra, Inc. · Apr 2018
GALAXY G3 Mini Microcoil Delivery System
K171862 · Codman & Shurtleff, Inc. · Sep 2017
POD Packing Coil
K170852 · Penumbra, Inc. · Jul 2017
MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil Delivery System
K171747 · Codman & Shurtleff, Inc. · Jul 2017