Cleared Traditional

K850043 - CARDIOGUARD STRESS TEST MONITOR 4002

K850043 is an FDA 510(k) clearance for CARDIOGUARD STRESS TEST MONITOR 4002, manufactured by Del Mar Avionics. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K850043 · Del Mar Avionics · Cardiovascular device
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Feb 1985
Decision
32d
Days
Class 2
Risk

K850043 is an FDA 510(k) clearance for the CARDIOGUARD STRESS TEST MONITOR 4002. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Del Mar Avionics (Irvine, US). The FDA issued a Cleared decision on February 8, 1985 after a review of 32 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 Del Mar Avionics devices

FDA 510(k) Submission Details - K850043

510(k) Number K850043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 1985
Decision Date February 08, 1985
Days to Decision 32 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 125d · This submission: 32d
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 216
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K850043.
KONTRON MINIMON 7131 PATIENT MONITOR
K844733 · Kontron Instruments, Inc. · Mar 1985
LS 5
K842037 · Life Science Instrumentation, Inc. · Mar 1985
C/PES 9201, ECG STRESS TESTING SYS
K850114 · Gould, Inc. · Feb 1985
C/PES 9103, ECG STRESS TESTING SYSTEM
K850113 · Gould, Inc. · Feb 1985
SPACELABS SERIES 600 PATIENT MONITORS
K844888 · Spacelabs, Inc. · Feb 1985
PATIENT MONITOR 78354A
K842236 · Hewlett-Packard Co. · Jan 1985