Cleared Traditional

K884897 - FOUR-CHANNEL/EIGHT-CHANNEL THERMAL ARRAY RECORDER (FDA 510(k) Clearance)

Class I Cardiovascular device.

K884897 · Mennen Medical, Inc. · Cardiovascular device
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Mar 1989
Decision
106d
Days
Class 1
Risk

K884897 is an FDA 510(k) clearance for the FOUR-CHANNEL/EIGHT-CHANNEL THERMAL ARRAY RECORDER. Classified as Recorder, Paper Chart (product code DSF), Class I - General Controls.

Submitted by Mennen Medical, Inc. (Clarence, US). The FDA issued a Cleared decision on March 9, 1989 after a review of 106 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 Mennen Medical, Inc. devices

Submission Details

510(k) Number K884897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1988
Decision Date March 09, 1989
Days to Decision 106 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 125d · This submission: 106d
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.