Cleared Traditional

K890711 - DUAL GRAPH (TM) RECORDER-MONITOR

K890711 is an FDA 510(k) clearance for DUAL GRAPH (TM) RECORDER-MONITOR, manufactured by Somatics, Inc.. The device is a Class 1 Cardiovascular device with product code DSF cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K890711 · Somatics, Inc. · Cardiovascular device
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Jun 1989
Decision
109d
Days
Class 1
Risk

K890711 is an FDA 510(k) clearance for the DUAL GRAPH (TM) RECORDER-MONITOR. Classified as Recorder, Paper Chart (product code DSF), Class I - General Controls.

Submitted by Somatics, Inc. (Lake Bluff, US). The FDA issued a Cleared decision on June 2, 1989 after a review of 109 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K890711

510(k) Number K890711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1989
Decision Date June 02, 1989
Days to Decision 109 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
16d faster than avg
Panel avg: 125d · This submission: 109d
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 86
Devices cleared under the same product code (DSF) and FDA review panel - the closest regulatory comparables to K890711.
PAQ10 PAPER CHART RECORDER
K894607 · Protocol Systems, Inc. · Oct 1989
EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM.
K893561 · Edentec Corp. · Aug 1989
CARDIOCAP(TM) DR-104 REPORTER
K885058 · Datex Division Instrumentarium Corp. · Jul 1989
FOUR-CHANNEL/EIGHT-CHANNEL THERMAL ARRAY RECORDER
K884897 · Mennen Medical, Inc. · Mar 1989
A10 ULTRASCOPE RECORDER
K890142 · Ems Medical, Inc. · Feb 1989
CORTRONIC SCR1000
K884911 · Cortronic Corp. · Jan 1989
K890711 · DUAL GRAPH (TM) RECORDER-MONITOR
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