Cleared Traditional

K803224 - ADVANCEMED HOLTER RECORDERS

K803224 is the FDA 510(k) clearance for ADVANCEMED HOLTER RECORDERS by American Edwards Laboratories. It is a Class 2 Cardiovascular device (product code DSH) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K803224 · American Edwards Laboratories · Cardiovascular device
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Jan 1981
Decision
25d
Days
Class 2
Risk

K803224 is an FDA 510(k) clearance for the ADVANCEMED HOLTER RECORDERS. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by American Edwards Laboratories (Mchenry, 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 870.2800 - 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 K803224 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. No clinical trials required.

Device Classification

Product Code DSH Recorder, Magnetic Tape, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DSH Recorder, Magnetic Tape, Medical

All 72
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K803224.
HOLTER RECORDER & PLAYBACK/ANALYSIS SYS
K822818 · Marquette Electronics, Inc. · Dec 1982
CASSETTE READER
K811253 · American Edwards Laboratories · Jul 1981
ADVANCEMED CCU DOCUMENTOR
K803222 · American Edwards Laboratories · Jan 1981
MODEL 9200 VIS-U-SCAN
K801832 · Del Mar Avionics · Aug 1980
AMBULATORY MONITOR AM-1
K801001 · Burdick Corp. · May 1980
MODEL 448 PACERCORDER
K792076 · Del Mar Avionics · Dec 1979