Cleared Traditional

K112565 - NOVAPORT ONE VASCULAR ACCESS CANNULA

K112565 is an FDA 510(k) clearance for NOVAPORT ONE VASCULAR ACCESS CANNULA, manufactured by Novalung GmbH. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K112565 · Novalung GmbH · Cardiovascular device
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Dec 2011
Decision
95d
Days
Class 2
Risk

K112565 is an FDA 510(k) clearance for the NOVAPORT ONE VASCULAR ACCESS CANNULA. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Novalung GmbH (Ann Arbor, US). The FDA issued a Cleared decision on December 6, 2011 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4210 - 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 Novalung GmbH devices

FDA 510(k) Submission Details - K112565

510(k) Number K112565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2011
Decision Date December 06, 2011
Days to Decision 95 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 125d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWF Device Classification - Class 2, Special Controls

Product Code DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4210
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 - DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

All 303
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K112565.
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