Cleared Traditional

K864614 - LP-3 ELECTROCARDIOGRAPH

K864614 is an FDA 510(k) clearance for LP-3 ELECTROCARDIOGRAPH, manufactured by Fidelity Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K864614 · Fidelity Medical, Inc. · Cardiovascular device
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Jun 1987
Decision
204d
Days
Class 2
Risk

K864614 is an FDA 510(k) clearance for the LP-3 ELECTROCARDIOGRAPH. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Fidelity Medical, Inc. (Millburn, US). The FDA issued a Cleared decision on June 16, 1987 after a review of 204 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 Fidelity Medical, Inc. devices

FDA 510(k) Submission Details - K864614

510(k) Number K864614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1986
Decision Date June 16, 1987
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.

DPS Device Classification - Class 2, Special Controls

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 336
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K864614.
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
ACUSON PHYSIOLOGICAL CONTROL MODULE
K871239 · Acuson Computed Sonography · Jun 1987
Q5000 STRESS TEST MONITOR
K864504 · Quinton, Inc. · Apr 1987
EK10 ELECTROCARDIOGRAPH
K870880 · Burdick Corp. · Apr 1987