Cleared Special

K121532 - HERO GRAFT

K121532 is an FDA 510(k) clearance for HERO GRAFT, manufactured by Hemosphere, Inc.. The device is a Class 2 Cardiovascular device with product code DSY cleared through the Special 510(k) pathway after a 29-day FDA review.

K121532 · Hemosphere, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
29d
Days
Class 2
Risk

K121532 is an FDA 510(k) clearance for the HERO GRAFT. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Hemosphere, Inc. (Eden Prarie, US). The FDA issued a Cleared decision on June 22, 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 870.3450 - 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 - K121532

510(k) Number K121532 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2012
Decision Date June 22, 2012
Days to Decision 29 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

DSY Device Classification - Class 2, Special Controls

Product Code DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3450
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 - DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

All 172
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K121532.
HERO GRAFT
K124039 · Hemoshpere, Inc., A Cryolife Company · Mar 2013
LIFESPAN EPTFE VASCULAR GRAFT
K130016 · LeMaitre Vascular, Inc. · Feb 2013
ATRIUM FLIXENE IFG VASCULAR GRAFT
K122138 · Atrium Medical Corp. · Aug 2012
HERO GRAFT
K120006 · Hemosphere, Inc. · Feb 2012
EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL
K113101 · Boston Scientific Corporation · Jan 2012
CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES
K103347 · Intervascular Sas · Feb 2011
K121532 · HERO GRAFT
Download PDF FDA Summary Hemosphere, Inc.