Cleared Special

K113822 - QUADRASPHERE 30 TO 60

K113822 is an FDA 510(k) clearance for QUADRASPHERE 30 TO 60, manufactured by Biosphere Medical, Inc.. The device is a Class 2 Neurology device with product code HCG cleared through the Special 510(k) pathway after a 72-day FDA review.

K113822 · Biosphere Medical, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
72d
Days
Class 2
Risk

K113822 is an FDA 510(k) clearance for the QUADRASPHERE 30 TO 60. Classified as Device, Neurovascular Embolization (product code HCG), Class II - Special Controls.

Submitted by Biosphere Medical, Inc. (Rockland, US). The FDA issued a Cleared decision on March 8, 2012 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5950 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K113822

510(k) Number K113822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2011
Decision Date March 08, 2012
Days to Decision 72 days
Submission Type Special
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
77d faster than avg
Panel avg: 149d · This submission: 72d
Pathway characteristics
Modification to existing cleared device.

HCG Device Classification - Class 2, Special Controls

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 185
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K113822.
TARGET DETACHABLE COIL
K120850 · Stryker Neurovascular · Apr 2012
ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM
K120686 · Codman & Shurtleff, Inc. · Apr 2012
PENUMBRA COIL SYSTEM/PENUMBRA COIL 400
K120330 · Penumbra, Inc. · Apr 2012
DELTAMAXX 18 MICROCOIL SYSTEM
K120274 · Codman and Shurtleff, Inc. · Mar 2012
HYDROCOIL EMBOLIC SYSTEM (HES)
K113457 · MicroVention, Inc. · Dec 2011
TARGET DETACHABLE COIL
K113412 · Stryker Neurovascular · Dec 2011
K113822 · QUADRASPHERE 30 TO 60
Download PDF FDA Summary Biosphere Medical, In…