Cleared Traditional

K811254 - PAPER CHART RECORDER (FDA 510(k) Clearance)

Class I Cardiovascular device.

K811254 · American Edwards Laboratories · Cardiovascular device
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Jul 1981
Decision
66d
Days
Class 1
Risk

K811254 is an FDA 510(k) clearance for the PAPER CHART RECORDER. Classified as Recorder, Paper Chart (product code DSF), Class I - General Controls.

Submitted by American Edwards Laboratories (Mchenry, US). The FDA issued a Cleared decision on July 10, 1981 after a review of 66 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K811254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1981
Decision Date July 10, 1981
Days to Decision 66 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 125d · This submission: 66d
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.