Cleared Traditional

K790004 - MONITOR SCOPES

K790004 is the FDA 510(k) clearance for MONITOR SCOPES by C-V Monitors Corp.. It is a Class 2 Cardiovascular device (product code DRT) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K790004 · C-V Monitors Corp. · Cardiovascular device
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Feb 1979
Decision
57d
Days
Class 2
Risk

K790004 is an FDA 510(k) clearance for the MONITOR SCOPES, MODELS 9502, 9503. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by C-V Monitors Corp. (Mchenry, US). The FDA issued a Cleared decision on February 28, 1979 after a review of 57 days - a notably fast clearance 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: 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 C-V Monitors Corp. devices

Submission Details

510(k) Number K790004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1979
Decision Date February 28, 1979
Days to Decision 57 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 125d · This submission: 57d
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 156
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K790004.
A-V MINI CLINIC
K800405 · Instromedix, Inc. · Jul 1980
HEART RATE MONITOR MD-1
K792312 · Medical Devices, Inc. · Nov 1979
MODEL 78801A PATIENT MONITORS
K790454 · Hewlett-Packard Co. · Apr 1979
MONITOR, ELECTROCARDIOSCOPE
K790292 · Burdick Corp. · Feb 1979
CSS-60 DIGITAL HEART RATE METER
K780702 · Burdick Corp. · May 1978
ECG MONITORING SYSTEM,
K780404 · Quinton, Inc. · Mar 1978