Cleared Traditional

K872658 - MODEL 980-CARDIOSCOPE AT-3 ELECTROCARDI...

K872658 is the FDA 510(k) clearance for MODEL 980-CARDIOSCOPE AT-3 ELECTROCARDI... by Del Mar Avionics. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K872658 · Del Mar Avionics · Cardiovascular device
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Jan 1988
Decision
183d
Days
Class 2
Risk

K872658 is an FDA 510(k) clearance for the MODEL 980-CARDIOSCOPE AT-3 ELECTROCARDIOGRAPH. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Del Mar Avionics (Irvine, US). The FDA issued a Cleared decision on January 6, 1988 after a review of 183 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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 Del Mar Avionics devices

Submission Details

510(k) Number K872658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1987
Decision Date January 06, 1988
Days to Decision 183 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
58d slower than avg
Panel avg: 125d · This submission: 183d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 252
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K872658.
MINIMON 7132B PATIENT MONITOR
K882198 · Kontron Instruments, Inc. · Jul 1988
HORIZON 2000/S 266-XXX-XXX
K880595 · Mennen Medical, Inc. · May 1988
FUKUDA MODEL DS-503 DYNASCOPE PATIENT MONITOR
K875057 · Fukuda Denshi USA, Inc. · Mar 1988
FITNESS RECUMBENT ERGOMETER, MODEL FT1400
K872548 · Invacare Corp. · Dec 1987
MODIFIED Q4000 & Q3040 ELECTROCARDIOGRAPH MONITOR
K873584 · Quinton, Inc. · Oct 1987
MODEL 2240 SLAVE SCOPE
K873346 · Marquette Electronics, Inc. · Oct 1987