Cleared Special

K250610 - Easyflow (103-200 (FDA 510(k) Clearance)

Also includes:
103-300) Easyflow Duo (103-210 103-310)

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

K250610 · Sorin Group Italia S.R.L. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jun 2025
Decision
119d
Days
Class 2
Risk

K250610 is an FDA 510(k) clearance for the Easyflow (103-200. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Sorin Group Italia S.R.L. (Mirandola, IT). The FDA issued a Cleared decision on June 27, 2025 after a review of 119 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. 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. Standard predicate reliance. 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 K250610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2025
Decision Date June 27, 2025
Days to Decision 119 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
6d faster than avg
Panel avg: 125d · This submission: 119d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 Consultant

LivaNova USA, Inc.
Jennifer Houck

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 - DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

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