Cleared Traditional

MONITOR, HEART RATE (K781166) - FDA 510(k) Clearance

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

K781166 · Cybernetic Medical, Inc. · Cardiovascular device
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Oct 1978
Decision
95d
Days
Class 2
Risk

K781166 is an FDA 510(k) clearance for the MONITOR, HEART RATE. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Cybernetic Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 15, 1978 after a review of 95 days - within the typical 510(k) review window.

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.

View all Cybernetic Medical, Inc. devices

Submission Details

510(k) Number K781166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1978
Decision Date October 15, 1978
Days to Decision 95 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 125d · This submission: 95d
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 42
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K781166.
RESIDENT BEDSIDE MONITOR
K811216 · Abbott Laboratories · Jul 1981
PDS COMPUTER UNIT/VIDEO TERMINAL
K801761 · General Electric Co. · Aug 1980
MODEL 78801A PATIENT MONITORS
K790454 · Hewlett-Packard Co. · Apr 1979
ECG SCOPE MODEL 7833
K771360 · Hewlett-Packard Co. · Aug 1977
MONITOR, NEONATAL, MODEL 78261A
K770022 · Hewlett-Packard Co. · Feb 1977
MONITOR, NEONATE, MODEL 78213A
K770023 · Hewlett-Packard Co. · Feb 1977