Cleared Traditional

MT96000 PAPER CHART RECORDER (K894736) - FDA 510(k) Clearance

Class I Cardiovascular device.

K894736 · Astro-Med, Inc. · Cardiovascular device
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Dec 1989
Decision
139d
Days
Class 1
Risk

K894736 is an FDA 510(k) clearance for the MT96000 PAPER CHART RECORDER. Classified as Recorder, Paper Chart (product code DSF), Class I - General Controls.

Submitted by Astro-Med, Inc. (West Warwick, US). The FDA issued a Cleared decision on December 13, 1989 after a review of 139 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 Astro-Med, Inc. devices

Submission Details

510(k) Number K894736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1989
Decision Date December 13, 1989
Days to Decision 139 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 125d · This submission: 139d
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.