Cleared Traditional

K803225 - ADVANCEMED EXAMINER

K803225 is the FDA 510(k) clearance for ADVANCEMED EXAMINER by American Edwards Laboratories. It is a Class 1 Cardiovascular device (product code DSF) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K803225 · American Edwards Laboratories · Cardiovascular device
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Jan 1981
Decision
25d
Days
Class 1
Risk

K803225 is an FDA 510(k) clearance for the ADVANCEMED EXAMINER. Classified as Recorder, Paper Chart (product code DSF), Class I - General Controls.

Submitted by American Edwards Laboratories (Walker, US). The FDA issued a Cleared decision on January 13, 1981 after a review of 25 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 K803225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1980
Decision Date January 13, 1981
Days to Decision 25 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
100d faster than avg
Panel avg: 125d · This submission: 25d
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 K803225.
1,2,3 CHANNELL RECORDERS (AR150,AR250,-)
K810166 · Honeywell, Inc. · Feb 1981
SINGLE CHANNELL RECORDER AR110
K810167 · Honeywell, Inc. · Feb 1981
CENTRAL STATION CONTROLLER AC100/CE100
K810169 · Honeywell, Inc. · Feb 1981
MODEL 9300 ELECTROCARDIOVALIDATOR
K801830 · Del Mar Avionics · Aug 1980
CRITIKON DUAL CHANNEL RECORDER
K792105 · Critikon Company, LLC · Oct 1979
LS-8 VISICORDER
K790825 · Honeywell, Inc. · May 1979