Cleared Traditional

K162373 - LC Bead LUMI

K162373 is an FDA 510(k) clearance for LC Bead LUMI, manufactured by Biocompatibles UK Limited. The device is a Class 2 Cardiovascular device with product code KRD cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K162373 · Biocompatibles UK Limited · Cardiovascular device
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Dec 2016
Decision
114d
Days
Class 2
Risk

K162373 is an FDA 510(k) clearance for the LC Bead LUMI. Classified as Device, Vascular, For Promoting Embolization (product code KRD), Class II - Special Controls.

Submitted by Biocompatibles UK Limited (Farnham, GB). The FDA issued a Cleared decision on December 16, 2016 after a review of 114 days - within the typical 510(k) review window.

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 Biocompatibles UK Limited devices

FDA 510(k) Submission Details - K162373

510(k) Number K162373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2016
Decision Date December 16, 2016
Days to Decision 114 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 125d · This submission: 114d
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 98
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K162373.
Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume
K173891 · Vascular Solutions, Inc. · Jan 2018
Gel-Bead
K171946 · Vascular Solutions, Inc. · Oct 2017
AZUR CX Detachable 18 Peripheral Coil System
K162524 · MicroVention, Inc. · Mar 2017
Hilal Embolization MicroCoils
K160219 · Cook Incorporated · Aug 2016
Nester Embolization Coils, Tornado Embolization Coils
K153778 · Cook Incorporated · May 2016
HydroPearl Microspheres, HydroPearl Microspheres
K150870 · MicroVention, Inc. · Dec 2015