Cleared Traditional

K904696 - WEP-8430A TELEMETRY CENTRAL STATION

K904696 is an FDA 510(k) clearance for WEP-8430A TELEMETRY CENTRAL STATION, manufactured by Nihon Kohden America, Inc.. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K904696 · Nihon Kohden America, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K904696

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.

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 167
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K904696.
DATASCOPE PASSPORT MONITOR
K911598 · Datascope Corp. · Oct 1991
HORIZON XL
K911616 · Mennen Medical, Inc. · Jul 1991
HEWLETT-PACKARD MODELS M1400A, M1402A & M1401A
K911139 · Hewlett-Packard Co. · Jun 1991
MORTARA INSTRUMENT MODEL ELI 50
K902652 · Mortara Instrument, Inc. · Aug 1990
TYPE 9040/NEO
K896699 · S & W Medico Teknik · Apr 1990
TYPE 9140/NEO
K896700 · S & W Medico Teknik · Apr 1990