Cleared Traditional

K894922 - WR3500 AND WR3600 SERIES RECORDERS

K894922 is an FDA 510(k) clearance for WR3500 AND WR3600 SERIES RECORDERS, manufactured by Western Graphtec. The device is a Class 1 Cardiovascular device with product code DSF cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K894922 · Western Graphtec · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K894922

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.

DSF Device Classification - Class 1, General Controls

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 57
Devices cleared under the same product code (DSF) and FDA review panel - the closest regulatory comparables to K894922.
EDENTEC DIGITAL CHARTER MODEL 3710
K910871 · Edentec Corp. · Aug 1991
MODEL 556 MONITOR
K905856 · Ge Medical Systems Information Technologies · Jan 1991
COLORADO COLOR IMAGING RECORDER
K902230 · Honeywell, Inc. · Jun 1990
TYPE 9541 RECORDER, PAPER CHART
K895111 · S & W Medico Teknik · Jan 1990
EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM.
K893561 · Edentec Corp. · Aug 1989
CARDIOCAP(TM) DR-104 REPORTER
K885058 · Datex Division Instrumentarium Corp. · Jul 1989