Cleared Special

INSPIRE 6M Hollow Fiber Oxygenator (K180448) - FDA 510(k) Clearance

Also marketed or referenced as:
INSPIRE 6F M Hollow Fiber Oxygenator with Integrated Arterial Filter INSPIRE 8M Hollow Fiber Oxygenator INSPIRE 8F M Hollow Fiber Oxygenator with Integrated Arterial Filter

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K180448 · Sorin Group Italia S.R.L. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
30d
Days
Class 2
Risk

K180448 is an FDA 510(k) clearance for the INSPIRE 6M Hollow Fiber Oxygenator. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Sorin Group Italia S.R.L. (Mirandola, IT). The FDA issued a Cleared decision on March 15, 2018 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4350 - 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.

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

Submission Details

510(k) Number K180448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2018
Decision Date March 15, 2018
Days to Decision 30 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
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 Consultant

LivaNova USA, Inc.
Scott Light

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DTZ Oxygenator, Cardiopulmonary Bypass

All 97
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K180448.
Affinity Pixie™ Oxygenator with Balance™ Biosurface (Model BBP211), Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir with Balance™ Biosurface (Model BBP241), Affinity Pixie™ Oxygenator with Cortiva™ BioActive Surface (Model CBP211), Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir with Cortiva™ BioActive Surface (Model CBP241)
K183511 · Medtronic, Inc. · Mar 2019
Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19 Oxygenator with Reservoir (west Orientation), Terumo Capiox NX19 Oxygenator (east Orientation), Terumo Capiox NX19 Oxygenator (west Orientation)
K180950 · Terumo Cardiovascular Systems Corporation · Jun 2018
Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox NX19 Oxygenator with Reservoir (west orientation ), Terumo Capiox NX19 Oxygenator (east orientation ), Terumo Capiox NX19 Oxygenator (west orientation)
K172071 · Terumo Cardiovascular Systems Corporation · Mar 2018
Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Pixie Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Cortiva BioActive Surface
K172984 · Medtronic, Inc. · Nov 2017
Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Fusion Oxygenator with Cortiva Biosurface, Affinity Fusion Oxygenator with Cortiva BioActive Surface & Cardiotomy/Venous Reservoir
K172626 · Medtronic, Inc. · Oct 2017
Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface
K162896 · Medtronic, Inc. · Dec 2016