Cleared Traditional

TRU-VIEW MULTI-CHANNEL DISPLAY (K912008) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K912008 · General Devices · Cardiovascular device
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Oct 1991
Decision
156d
Days
Class 2
Risk

K912008 is an FDA 510(k) clearance for the TRU-VIEW MULTI-CHANNEL DISPLAY. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by General Devices (Bogota, US). The FDA issued a Cleared decision on October 9, 1991 after a review of 156 days - an extended review cycle.

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: 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.

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Submission Details

510(k) Number K912008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1991
Decision Date October 09, 1991
Days to Decision 156 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
31d slower than avg
Panel avg: 125d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 41
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K912008.
Vios Monitoring System™ Model 2050
K172586 · Vios Medical, Inc. · Jun 2018
SIEMENS INFINITY SC 6002XL MODIFICATIONS
K020144 · Siemens Medical Solutions USA, Inc. · Feb 2002
HEWLETT-PACKARD CARDIAC CATHETERIZATION RECORDING
K921194 · Hewlett-Packard Co. · Nov 1992
HEWLETT-PACKARD MODELS M1400A, M1402A & M1401A
K911139 · Hewlett-Packard Co. · Jun 1991
MODEL M1175A/M1176A WITH ST SEGMENT MONITORING
K900032 · Hewlett-Packard Co. · Apr 1990
SIRECUST 341 AND 341R
K854881 · Siemens Medical Solutions USA, Inc. · Mar 1986