Cleared Traditional

DEMODULATOR/CARDIOTACHOMETER (K761076) - FDA 510(k) Clearance

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

K761076 · Eldeco · Cardiovascular device
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Dec 1976
Decision
39d
Days
Class 2
Risk

K761076 is an FDA 510(k) clearance for the DEMODULATOR/CARDIOTACHOMETER. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Eldeco (Mchenry, US). The FDA issued a Cleared decision on December 28, 1976 after a review of 39 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 Eldeco devices

Submission Details

510(k) Number K761076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1976
Decision Date December 28, 1976
Days to Decision 39 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 125d · This submission: 39d
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 K761076.
MONITOR, NEONATAL, MODEL 78261A
K770022 · Hewlett-Packard Co. · Feb 1977
MONITOR, NEONATE, MODEL 78213A
K770023 · Hewlett-Packard Co. · Feb 1977
MONITOR, NEONATAL, MODEL 78260A
K770024 · Hewlett-Packard Co. · Feb 1977
CENTRAL STATION MONITORING SYSTEM
K761291 · Abbott Laboratories · Dec 1976
MODEL 15050A DIGITAL DISPLAY
K761211 · Hewlett-Packard Co. · Dec 1976
PORTABLE CARDIAC MONITOR, ABBY
K760593 · Abbott Laboratories · Sep 1976