Cleared Traditional

VENTURE II MONITORING SYSTEM (K830321) - FDA 510(k) Clearance

Class I Cardiovascular device.

K830321 · Rae Medical Corp. · Cardiovascular device
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Jun 1983
Decision
123d
Days
Class 1
Risk

K830321 is an FDA 510(k) clearance for the VENTURE II MONITORING SYSTEM. Classified as Recorder, Paper Chart (product code DSF), Class I - General Controls.

Submitted by Rae Medical Corp. (Mchenry, US). The FDA issued a Cleared decision on June 3, 1983 after a review of 123 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.

View all Rae Medical Corp. devices

Submission Details

510(k) Number K830321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1983
Decision Date June 03, 1983
Days to Decision 123 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 125d · This submission: 123d
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 16
Devices cleared under the same product code (DSF) and FDA review panel - the closest regulatory comparables to K830321.
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
SIREDOC, PAPER CHART RECORDER
K850146 · Siemens Medical Solutions USA, Inc. · Feb 1985
DUAL CHANNEL RECORDER #78574A
K830315 · Hewlett-Packard Co. · Mar 1983
MODEL 525 NEO-TRAK NEONATAL RECORDER
K823210 · Ge Medical Systems Information Technologies · Nov 1982
ECG PAPER, 3 CHANNEL
K780597 · Abco Dealers, Inc. · Jun 1978