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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
254d slower than avg
Panel avg: 149d · 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 129
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K052742.
AMPLATZER VASCULAR PLUG II, MODELS AVP2-003, AVP2-018, AVP2-020, AVP2-022
K071699 · Aga Medical Corp. · Aug 2007
AMPLATZER VASCULAR PLUG II MODELS: AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012, AVP2-014, AVP2-016
K071125 · Aga Medical Corp. · Jun 2007
FLIPPER DETACHABLE EMBOLIZATION COILS
K063619 · Cook, Inc. · Dec 2006
PVA PLUS, MAXISTAT PVA, MICROSTAT PVA FOAM EMBOLIZATION PARTICLES
K061790 · Protein Polymer Technologies, Inc. · Sep 2006
FIBERED IDC OCCLUSION SYSTEM
K060078 · Boston Scientific Corporation · Jan 2006
MREYE EMBOLIZATION COIL
K052834 · Cook, Inc. · Nov 2005
K052742 · HEPASPHERE MICROSPHERES
Download PDF FDA Summary Biosphere Medical, In…