Cleared Traditional

K894340 - PCI MODEL 2041-A TELEMETRY MONITOR

K894340 is an FDA 510(k) clearance for PCI MODEL 2041-A TELEMETRY MONITOR, manufactured by Accucore, Inc.. The device is a Class 2 Cardiovascular device with product code DXH cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K894340 · Accucore, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1989
Decision
80d
Days
Class 2
Risk

K894340 is an FDA 510(k) clearance for the PCI MODEL 2041-A TELEMETRY MONITOR. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Accucore, Inc. (Santa Ana, US). The FDA issued a Cleared decision on October 2, 1989 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2920 - 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 - K894340

510(k) Number K894340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1989
Decision Date October 02, 1989
Days to Decision 80 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 125d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXH Device Classification - Class 2, Special Controls

Product Code DXH Transmitters And Receivers, Electrocardiograph, Telephone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2920
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 - DXH Transmitters And Receivers, Electrocardiograph, Telephone

All 194
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K894340.
KING OF HEARTS 1200 MONITOR
K896039 · Instromedix, Inc. · Feb 1990
CARRY-ALL EKG TRANSTELEPHONIC TRANSMITTER
K896002 · Instromedix, Inc. · Jan 1990
TELEMETRY RECEIVER ACCESSORY FOR THE CMS 8000
K894540 · Physio-Control Corp. · Oct 1989
MEDTRONIC MODEL 9444 TELETRACE II ECG MONITORING
K893471 · Medtronic Vascular · Sep 1989
M1400A TRANSMITTER,M1402 RECEIVER,M1401 MAINFRAME
K894277 · Hewlett-Packard Co. · Sep 1989
MEDTRONIC MODEL 9443 IN-OFFICE TRANSMITTER
K894140 · Medtronic Vascular · Jul 1989