Cleared Traditional

K052742 - HEPASPHERE MICROSPHERES

K052742 is an FDA 510(k) clearance for HEPASPHERE MICROSPHERES, manufactured by Biosphere Medical, Inc.. The device is a Class 2 Neurology device with product code KRD cleared through the Traditional 510(k) pathway after a 403-day FDA review.

K052742 · Biosphere Medical, Inc. · Neurology device
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Nov 2006
Decision
403d
Days
Class 2
Risk

K052742 is an FDA 510(k) clearance for the HEPASPHERE MICROSPHERES. Classified as Device, Vascular, For Promoting Embolization (product code KRD), Class II - Special Controls.

Submitted by Biosphere Medical, Inc. (North Attleboro, US). The FDA issued a Cleared decision on November 7, 2006 after a review of 403 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.3300 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Biosphere Medical, Inc. devices

FDA 510(k) Submission Details - K052742

510(k) Number K052742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2005
Decision Date November 07, 2006
Days to Decision 403 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
255d slower than avg
Panel avg: 148d · This submission: 403d
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 Neurology 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 K052742.
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K063619 · Cook, Inc. · Dec 2006
FIBERED IDC OCCLUSION SYSTEM
K060078 · Boston Scientific Corporation · Jan 2006
MREYE EMBOLIZATION COIL
K052834 · Cook, Inc. · Nov 2005
CONCENTRIC EMBOLIC PEARLS
K050470 · Concentric Medical, Inc. · May 2005