Cleared Traditional

K926298 - 520 DISPLAY DRIVER- STATUS I

K926298 is an FDA 510(k) clearance for 520 DISPLAY DRIVER- STATUS I, manufactured by Vidco, Inc.. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 506-day FDA review.

K926298 · Vidco, Inc. · Cardiovascular device
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May 1994
Decision
506d
Days
Class 2
Risk

K926298 is an FDA 510(k) clearance for the 520 DISPLAY DRIVER- STATUS I. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Vidco, Inc. (Beaverton, US). The FDA issued a Cleared decision on May 4, 1994 after a review of 506 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

FDA 510(k) Submission Details - K926298

510(k) Number K926298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1992
Decision Date May 04, 1994
Days to Decision 506 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
381d slower than avg
Panel avg: 125d · This submission: 506d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRT Device Classification - Class 2, Special Controls

Product Code DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

All 324
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K926298.
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ESCORT 100/300 SERIES B PATIENT MONITORS
K930004 · Medical Data Electronics · Jun 1993
SYSTEM ATHENA, MODIFICATION
K911611 · S & W Medico Teknik · Feb 1993
K926298 · 520 DISPLAY DRIVER- STATUS I
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