Cleared Traditional

K902334 - MONITOR, MODEL 2817

K902334 is an FDA 510(k) clearance for MONITOR, manufactured by Esaote Biomedica Spa. The device is a Class 2 Cardiovascular device with product code DXJ cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K902334 · Esaote Biomedica Spa · Cardiovascular device
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Jun 1990
Decision
33d
Days
Class 2
Risk

K902334 is an FDA 510(k) clearance for the MONITOR, MODEL 2817. Classified as Display, Cathode-ray Tube, Medical (product code DXJ), Class II - Special Controls.

Submitted by Esaote Biomedica Spa (Cambridge, US). The FDA issued a Cleared decision on June 26, 1990 after a review of 33 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 Esaote Biomedica Spa devices

FDA 510(k) Submission Details - K902334

510(k) Number K902334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1990
Decision Date June 26, 1990
Days to Decision 33 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 125d · This submission: 33d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 66
Devices cleared under the same product code (DXJ) and FDA review panel - the closest regulatory comparables to K902334.
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K883973 · Nihon Kohden America, Inc. · Nov 1988