Cleared Special

K120816 - INZONE DETACHMENT SYSTEM

K120816 is an FDA 510(k) clearance for INZONE DETACHMENT SYSTEM, manufactured by Stryker. The device is a Class 2 Cardiovascular device with product code KRD cleared through the Special 510(k) pathway after a 29-day FDA review.

K120816 · Stryker · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
29d
Days
Class 2
Risk

K120816 is an FDA 510(k) clearance for the INZONE DETACHMENT SYSTEM. Classified as Device, Vascular, For Promoting Embolization (product code KRD), Class II - Special Controls.

Submitted by Stryker (Fremont, US). The FDA issued a Cleared decision on April 17, 2012 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3300 - the FDA cardiovascular device oversight 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 - K120816

510(k) Number K120816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2012
Decision Date April 17, 2012
Days to Decision 29 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 129
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K120816.
AZUR DETACHABLE 35
K122316 · MicroVention, Inc. · Aug 2012
AMPLATZER VASCULAR PLUG 4
K113658 · Aga Medical Corp. · Jun 2012
GEL-BLOCK EMBOLIZATION PLEDGETS
K113266 · Vascular Solutions, Inc. · May 2012
AZUR DETACHABLE 18
K120630 · MicroVention, Inc. · Mar 2012
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
K113651 · Boston Scientific Corporation · Jan 2012
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
K112103 · Boston Scientific Corp · Aug 2011
K120816 · INZONE DETACHMENT SYSTEM
Download PDF FDA Summary Stryker