Cleared Traditional

K780117 - CARDIOMETER

K780117 is the FDA 510(k) clearance for CARDIOMETER by Med General. It is a Class 2 Cardiovascular device (product code DRT) cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K780117 · Med General · Cardiovascular device
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Feb 1978
Decision
11d
Days
Class 2
Risk

K780117 is an FDA 510(k) clearance for the CARDIOMETER. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Med General (Mchenry, US). The FDA issued a Cleared decision on February 3, 1978 after a review of 11 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 Med General devices

Submission Details

510(k) Number K780117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1978
Decision Date February 03, 1978
Days to Decision 11 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 125d · This submission: 11d
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 92
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K780117.
MODEL 78801A PATIENT MONITORS
K790454 · Hewlett-Packard Co. · Apr 1979
ECG MONITORING SYSTEM,
K780404 · Quinton, Inc. · Mar 1978
MONITOR, CARDIAC, BEDSIDE
K772332 · Telectronics, Inc. · Feb 1978
ACUTE CARDIAC CARE SYSTEM
K772006 · Physio-Control Corp. · Nov 1977
PHYSIOLOGICAL MONITOR MODEL 871
K772056 · Datascope Corp. · Nov 1977
HEARTRATE METER MODEL 650, P/N 000119
K772097 · Quinton, Inc. · Nov 1977