Cleared Traditional

PCI MODEL 2041-PC TELEMETRY MONITOR (K901031) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K901031 · Accucore, Inc. · Cardiovascular device
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May 1990
Decision
72d
Days
Class 2
Risk

K901031 is an FDA 510(k) clearance for the PCI MODEL 2041-PC TELEMETRY MONITOR. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Accucore, Inc. (Santa Ana, US). The FDA issued a Cleared decision on May 17, 1990 after a review of 72 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 Accucore, Inc. devices

Submission Details

510(k) Number K901031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1990
Decision Date May 17, 1990
Days to Decision 72 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 125d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 55
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K901031.
HEWLETT-PACKARD CARDIAC CATHETERIZATION RECORDING
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HEWLETT-PACKARD MODELS M1400A, M1402A & M1401A
K911139 · Hewlett-Packard Co. · Jun 1991
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K904696 · Nihon Kohden America, Inc. · Feb 1991
MODELS WEP-8410A AND WEP-8420A TELEMETRY CENTRAL
K901034 · Nihon Kohden America, Inc. · Apr 1990
MODEL M1175A/M1176A WITH ST SEGMENT MONITORING
K900032 · Hewlett-Packard Co. · Apr 1990
LIFESCOPE 8, OEC-8120 PORTABLE PATIENT MONITOR REC
K862463 · Nihon Kohden America, Inc. · Dec 1986