Cleared Traditional

K864583 - CARDIAC PERFORMANCE MONITOR

K864583 is an FDA 510(k) clearance for CARDIAC PERFORMANCE MONITOR, manufactured by Vascular Technology Incorporated. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K864583 · Vascular Technology Incorporated · Cardiovascular device
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May 1987
Decision
172d
Days
Class 2
Risk

K864583 is an FDA 510(k) clearance for the CARDIAC PERFORMANCE MONITOR. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Vascular Technology Incorporated (Attleboro, US). The FDA issued a Cleared decision on May 11, 1987 after a review of 172 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - 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 Vascular Technology Incorporated devices

FDA 510(k) Submission Details - K864583

510(k) Number K864583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1986
Decision Date May 11, 1987
Days to Decision 172 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 125d · This submission: 172d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQK Device Classification - Class 2, Special Controls

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
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 - DQK Computer, Diagnostic, Programmable

All 308
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K864583.
EPICARDIA LE/FD
K881770 · Medicomp, Inc. · May 1988
MODEL 5650C CARDIOLOGY DATA MANAGEMENT SYSTEM
K874171 · Hewlett-Packard Co. · Feb 1988
MICOR
K865010 · Siemens Medical Solutions USA, Inc. · Jul 1987
QUINTON Q.CATH
K862740 · Quinton, Inc. · Oct 1986
PDS 9000 PATIENT DATA MGMT. SYSTEM
K855055 · Marquette Electronics, Inc. · Feb 1986
SIRECUST 425, RESPECTIVELY SIRECUST 430
K851637 · Siemens Medical Solutions USA, Inc. · Jul 1985