Cleared Traditional

HEARTWATCH (K800519) - FDA 510(k) Clearance

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

K800519 · D. Jenkins · Cardiovascular device
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Sep 1980
Decision
204d
Days
Class 2
Risk

K800519 is an FDA 510(k) clearance for the HEARTWATCH. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by D. Jenkins (Walker, US). The FDA issued a Cleared decision on September 26, 1980 after a review of 204 days - an extended review 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: 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 D. Jenkins devices

Submission Details

510(k) Number K800519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1980
Decision Date September 26, 1980
Days to Decision 204 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 125d · This submission: 204d
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 69
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K800519.
MODEL 2000 MONITOR
K812828 · Datascope Corp. · Nov 1981
CENTRAL STATION MONITOR
K812271 · Datascope Corp. · Aug 1981
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 MONITORING SYSTEM,
K780404 · Quinton, Inc. · Mar 1978