Cleared Traditional

K854369 - WEP 7604 TELEMETRY MONITOR

K854369 is an FDA 510(k) clearance for WEP 7604 TELEMETRY MONITOR, manufactured by Nihon Kohden America, Inc.. The device is a Class 2 Cardiovascular device with product code DXH cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K854369 · Nihon Kohden America, Inc. · Cardiovascular device
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Feb 1986
Decision
122d
Days
Class 2
Risk

K854369 is an FDA 510(k) clearance for the WEP 7604 TELEMETRY MONITOR. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Nihon Kohden America, Inc. (Irvine, US). The FDA issued a Cleared decision on February 28, 1986 after a review of 122 days - within the typical 510(k) review window.

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: 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 Nihon Kohden America, Inc. devices

FDA 510(k) Submission Details - K854369

510(k) Number K854369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1985
Decision Date February 28, 1986
Days to Decision 122 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 125d · This submission: 122d
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 115
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K854369.
KING OF HEARTS
K880626 · Instromedix, Inc. · Apr 1988
STAND. CLEAR VINYL DISPOSABLE ECG ELECT.(597 ADHE)
K872869 · Labeltape Meditect, Inc. · Nov 1987
MEDTRONIC MODEL 4220 AMBULATORY ECG MONITOR
K870652 · Medtronic Vascular · May 1987
CMS 8000
K853096 · Physio-Control Corp. · Jan 1986
#9431 TELETRACE, TELEPHONE, EKG TRANSMITTER
K852971 · Medtronic Vascular · Oct 1985
MDE ESCORT 1000 & MDE ESCOR 2000
K842716 · Medical Data Electronics · Feb 1985