Cleared Traditional

K800519 - HEARTWATCH

K800519 is an FDA 510(k) clearance for HEARTWATCH, manufactured by D. Jenkins. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 204-day FDA review.

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

FDA 510(k) Submission Details - K800519

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.

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 229
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K800519.
CENTRAL STATION MONITOR
K812271 · Datascope Corp. · Aug 1981
RESIDENT BEDSIDE MONITOR
K811216 · Abbott Laboratories · Jul 1981
ADVANCMED ELIMINATOR
K803223 · American Edwards Laboratories · Jan 1981
PDS COMPUTER UNIT/VIDEO TERMINAL
K801761 · General Electric Co. · Aug 1980
A-V MINI CLINIC
K800405 · Instromedix, Inc. · Jul 1980
HEART RATE MONITOR MD-1
K792312 · Medical Devices, Inc. · Nov 1979