Cleared Traditional

K832012 - MEDICAL ELECTRONICS-PRINTER CLOCK (FDA 510(k) Clearance)

Class I Cardiovascular device.

K832012 · Litton Medical Electronics · Cardiovascular device
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Oct 1983
Decision
130d
Days
Class 1
Risk

K832012 is an FDA 510(k) clearance for the MEDICAL ELECTRONICS-PRINTER CLOCK. Classified as Recorder, Paper Chart (product code DSF), Class I - General Controls.

Submitted by Litton Medical Electronics (Mchenry, US). The FDA issued a Cleared decision on October 31, 1983 after a review of 130 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 Litton Medical Electronics devices

Submission Details

510(k) Number K832012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1983
Decision Date October 31, 1983
Days to Decision 130 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 125d · This submission: 130d
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.