Cleared Traditional

K121536 - INSPIRE 8F OXYGENATOR WITH INTEGRATED ARTERIAL FILTER & HARDSHELL RESERVOIR

K121536 is an FDA 510(k) clearance for INSPIRE 8F OXYGENATOR WITH INTEGRATED A..., manufactured by Sorin Group Italia S.R.L.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K121536

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.

DTZ Device Classification - Class 2, Special Controls

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 226
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