Cleared Traditional

K782089 - MONITOR, HEART RATE MODEL 103

K782089 is an FDA 510(k) clearance for MONITOR, manufactured by Roche Medical Electronics, Inc.. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K782089 · Roche Medical Electronics, Inc. · Cardiovascular device
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Jan 1979
Decision
21d
Days
Class 2
Risk

K782089 is an FDA 510(k) clearance for the MONITOR, HEART RATE MODEL 103. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Roche Medical Electronics, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 4, 1979 after a review of 21 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 Roche Medical Electronics, Inc. devices

FDA 510(k) Submission Details - K782089

510(k) Number K782089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1978
Decision Date January 04, 1979
Days to Decision 21 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 125d · This submission: 21d
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 220
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K782089.
AS7 & AS8 MONITORS
K790552 · Narco Air-Shields · May 1979
MODEL 78801A PATIENT MONITORS
K790454 · Hewlett-Packard Co. · Apr 1979
MONITOR, ELECTROCARDIOSCOPE
K790292 · Burdick Corp. · Feb 1979
CARDIAC MINISCOPE & MINIGRAPH
K780297 · Arco Medical Products Co. · May 1978
CSS-60 DIGITAL HEART RATE METER
K780702 · Burdick Corp. · May 1978
ECG MONITORING SYSTEM,
K780404 · Quinton, Inc. · Mar 1978