Cleared Traditional

K792312 - HEART RATE MONITOR MD-1

K792312 is an FDA 510(k) clearance for HEART RATE MONITOR MD-1, manufactured by Medical Devices, Inc.. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 5-day FDA review.

K792312 · Medical Devices, Inc. · Cardiovascular device
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Nov 1979
Decision
5d
Days
Class 2
Risk

K792312 is an FDA 510(k) clearance for the HEART RATE MONITOR MD-1. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Medical Devices, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 21, 1979 after a review of 5 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 Medical Devices, Inc. devices

FDA 510(k) Submission Details - K792312

510(k) Number K792312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1979
Decision Date November 21, 1979
Days to Decision 5 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 125d · This submission: 5d
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 166
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K792312.
ADVANCMED ELIMINATOR
K803223 · American Edwards Laboratories · Jan 1981
PDS COMPUTER UNIT/VIDEO TERMINAL
K801761 · General Electric Co. · Aug 1980
A-V MINI CLINIC
K800405 · Instromedix, Inc. · Jul 1980
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