Cleared Traditional

K261913 - X°Port Heart Preservation System

K261913 is an FDA 510(k) clearance for X°Port Heart Preservation System, manufactured by Traferox Technologies, Inc.. The device is a Class 2 Cardiovascular device with product code MSB cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K261913 · Traferox Technologies, Inc. · Cardiovascular device
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Sep 2026
Decision
100d
Days
Class 2
Risk

K261913 is an FDA 510(k) clearance for the X°Port Heart Preservation System. Classified as System And Accessories, Isolated Heart, Transport And Preservation (product code MSB), Class II - Special Controls.

Submitted by Traferox Technologies, Inc. (Mississauga, CA). The FDA issued a Cleared decision on September 16, 2026 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 876.5880 - 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 Traferox Technologies, Inc. devices

FDA 510(k) Submission Details - K261913

510(k) Number K261913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2026
Decision Date September 16, 2026
Days to Decision 100 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
25d faster than avg
Panel avg: 125d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MSB Device Classification - Class 2, Special Controls

Product Code MSB System And Accessories, Isolated Heart, Transport And Preservation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5880
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 - MSB System And Accessories, Isolated Heart, Transport And Preservation

All 11
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