Cleared Traditional

K073372 - ELECTROPHYSIOLOGY SYSTEMS INTEGRATOR (EPSI)

K073372 is an FDA 510(k) clearance for ELECTROPHYSIOLOGY SYSTEMS INTEGRATOR (EPSI), manufactured by Systemsone. The device is a Class 2 Cardiovascular device with product code DXJ cleared through the Traditional 510(k) pathway after a 4-day FDA review.

K073372 · Systemsone · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2007
Decision
4d
Days
Class 2
Risk

K073372 is an FDA 510(k) clearance for the ELECTROPHYSIOLOGY SYSTEMS INTEGRATOR (EPSI). Classified as Display, Cathode-ray Tube, Medical (product code DXJ), Class II - Special Controls.

Submitted by Systemsone (Anchorage, US). The FDA issued a Cleared decision on December 7, 2007 after a review of 4 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2450 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Systemsone devices

FDA 510(k) Submission Details - K073372

510(k) Number K073372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2007
Decision Date December 07, 2007
Days to Decision 4 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
121d faster than avg
Panel avg: 125d · This submission: 4d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

DXJ Device Classification - Class 2, Special Controls

Product Code DXJ Display, Cathode-ray Tube, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2450
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 - DXJ Display, Cathode-ray Tube, Medical

All 61
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