Cleared Traditional

WR3500 AND WR3600 SERIES RECORDERS (K894922) - FDA 510(k) Clearance

Class I Cardiovascular device.

K894922 · Western Graphtec · Cardiovascular device
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Jan 1990
Decision
177d
Days
Class 1
Risk

K894922 is an FDA 510(k) clearance for the WR3500 AND WR3600 SERIES RECORDERS. Classified as Recorder, Paper Chart (product code DSF), Class I - General Controls.

Submitted by Western Graphtec (Irvine, US). The FDA issued a Cleared decision on January 26, 1990 after a review of 177 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2810 - 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 Western Graphtec devices

Submission Details

510(k) Number K894922 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1989
Decision Date January 26, 1990
Days to Decision 177 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 125d · This submission: 177d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DSF Recorder, Paper Chart
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.2810
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - DSF Recorder, Paper Chart

All 15
Devices cleared under the same product code (DSF) and FDA review panel - the closest regulatory comparables to K894922.
MODEL 556 MONITOR
K905856 · Ge Medical Systems Information Technologies · Jan 1991
WS 800R THERMAL ARRAY RECORDER
K881831 · Nihon Kohden America, Inc. · Jul 1988
MODEL 78576A PAPER CHART RECORDER
K872822 · Hewlett-Packard Co. · Nov 1987
SIREDOC 60 AND SIREDOC 220
K863331 · Siemens Medical Solutions USA, Inc. · Oct 1986
MODEL 535 NEO-TRAK RECORDER
K855045 · Ge Medical Systems Information Technologies · May 1986
LONG TERM RECORDER RAG 1200
K854866 · Nihon Kohden America, Inc. · Apr 1986