Cleared Traditional

K901031 - PCI MODEL 2041-PC TELEMETRY MONITOR

K901031 is an FDA 510(k) clearance for PCI MODEL 2041-PC TELEMETRY MONITOR, manufactured by Accucore, Inc.. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 72-day FDA review.

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

FDA 510(k) Submission Details - K901031

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.

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 225
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K901031.
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MODELS WEP-8410A AND WEP-8420A TELEMETRY CENTRAL
K901034 · Nihon Kohden America, Inc. · Apr 1990