Cleared Traditional

K821173 - EVENTMASTER 3 HOLTER EVENT SCANNER

K821173 is an FDA 510(k) clearance for EVENTMASTER 3 HOLTER EVENT SCANNER, manufactured by Instruments For Cardiac Research. The device is a Class 1 Cardiovascular device with product code DSF cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K821173 · Instruments For Cardiac Research · Cardiovascular device
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May 1982
Decision
22d
Days
Class 1
Risk

K821173 is an FDA 510(k) clearance for the EVENTMASTER 3 HOLTER EVENT SCANNER. Classified as Recorder, Paper Chart (product code DSF), Class I - General Controls.

Submitted by Instruments For Cardiac Research (Mchenry, US). The FDA issued a Cleared decision on May 18, 1982 after a review of 22 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 Instruments For Cardiac Research devices

FDA 510(k) Submission Details - K821173

510(k) Number K821173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1982
Decision Date May 18, 1982
Days to Decision 22 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 125d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

DSF Device Classification - Class 1, General Controls

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 57
Devices cleared under the same product code (DSF) and FDA review panel - the closest regulatory comparables to K821173.
MODEL 525 NEO-TRAK NEONATAL RECORDER
K823210 · Ge Medical Systems Information Technologies · Nov 1982
CENTURION CHART RECORDER
K822432 · Clinical Data, Inc. · Nov 1982
MODEL 16800 TREND RECORDER
K821612 · Healthdyne, Inc. · Jul 1982
CARDIOVUE ACCESSORY CART
K820033 · Diasonics, Inc. · Jan 1982
VASCULAB #R12B
K812608 · Medasonics, Inc. · Oct 1981
SPACELABS' SYSTEM AUTORECORDER
K811540 · Spacelabs, Inc. · Aug 1981