Cleared Traditional

K121536 - INSPIRE 8F OXYGENATOR WITH INTEGRATED A...

K121536 is the FDA 510(k) clearance for INSPIRE 8F OXYGENATOR WITH INTEGRATED A... by Sorin Group Italia S.R.L.. It is a Class 2 Cardiovascular device (product code DTZ) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K121536 · Sorin Group Italia S.R.L. · Cardiovascular device
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Aug 2012
Decision
90d
Days
Class 2
Risk

K121536 is an FDA 510(k) clearance for the INSPIRE 8F OXYGENATOR WITH INTEGRATED ARTERIAL FILTER & HARDSHELL RESERVOIR. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Sorin Group Italia S.R.L. (Arvada, US). The FDA issued a Cleared decision on August 22, 2012 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4350 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Sorin Group Italia S.R.L. devices

Submission Details

510(k) Number K121536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2012
Decision Date August 22, 2012
Days to Decision 90 days
Submission Type Traditional
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
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTZ Oxygenator, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4350
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 - DTZ Oxygenator, Cardiopulmonary Bypass

All 162
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K121536.
INSPIRE 8F DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL RESERVOIR
K122844 · Sorin Group Italia S.R.L. · Oct 2012
AFFINITY PIXIE OXYGENATION SYSTEM WITH CARMEDA BIOACTIVE SURFACE OR BALANCE BIOSURFACE
K100645 · Medtronic, Inc. · Sep 2012
INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR
K122254 · Sorin Group Italia S.R.L. · Aug 2012
INSPIRE 6 DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVIOR
K121909 · Sorin Group Italia S.R.L. · Jul 2012
INSPIRE 8 DUAL HOLLOW FIBER OXYGENATOR WITH WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY
K121229 · Sorin Group Italia S.R.L. · Jul 2012
INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CARDIOTOMY RESERVIOR
K120185 · Sorin Group Italia S.R.L. · May 2012