Cleared Traditional

WEP-8430A TELEMETRY CENTRAL STATION (K904696) - FDA 510(k) Clearance

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

K904696 · Nihon Kohden America, Inc. · Cardiovascular device
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Feb 1991
Decision
176d
Days
Class 2
Risk

K904696 is an FDA 510(k) clearance for the WEP-8430A TELEMETRY CENTRAL STATION. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Nihon Kohden America, Inc. (Irvine, US). The FDA issued a Cleared decision on February 7, 1991 after a review of 176 days - an extended review 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: 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

Submission Details

510(k) Number K904696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1990
Decision Date February 07, 1991
Days to Decision 176 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
51d slower than avg
Panel avg: 125d · This submission: 176d
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 68
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K904696.
MODEL 556 MONITOR W/24-HR. TREND RECALL/MODIFIED
K910665 · Ge Medical Systems Information Technologies · Dec 1991
DATASCOPE PASSPORT MONITOR
K911598 · Datascope Corp. · Oct 1991
HEWLETT-PACKARD MODELS M1400A, M1402A & M1401A
K911139 · Hewlett-Packard Co. · Jun 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