Cleared Traditional

K811254 - PAPER CHART RECORDER

K811254 is the FDA 510(k) clearance for PAPER CHART RECORDER by American Edwards Laboratories. It is a Class 1 Cardiovascular device (product code DSF) cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K811254 · American Edwards Laboratories · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all American Edwards Laboratories devices

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
Combination Product No
PCCP Authorized No
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.

Regulatory Peers - DSF Recorder, Paper Chart

All 46
Devices cleared under the same product code (DSF) and FDA review panel - the closest regulatory comparables to K811254.
MODEL 16800 TREND RECORDER
K821612 · Healthdyne, Inc. · Jul 1982
CARDIOVUE ACCESSORY CART
K820033 · Diasonics, Inc. · Jan 1982
SPACELABS' SYSTEM AUTORECORDER
K811540 · Spacelabs, Inc. · Aug 1981
NOVATRACER RECORDER
K811453 · Novametrix Medical Systems, Inc. · Jul 1981
1,2,3 CHANNELL RECORDERS (AR150,AR250,-)
K810166 · Honeywell, Inc. · Feb 1981
SINGLE CHANNELL RECORDER AR110
K810167 · Honeywell, Inc. · Feb 1981