Cleared Traditional

HOLTA-MED INFORMER PLAYBACK (K832354) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K832354 · Holta-Med · Cardiovascular device
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Jan 1984
Decision
193d
Days
Class 2
Risk

K832354 is an FDA 510(k) clearance for the HOLTA-MED INFORMER PLAYBACK. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Holta-Med (Walker, US). The FDA issued a Cleared decision on January 27, 1984 after a review of 193 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Holta-Med devices

Submission Details

510(k) Number K832354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1983
Decision Date January 27, 1984
Days to Decision 193 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 125d · This submission: 193d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSI Detector And Alarm, Arrhythmia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - DSI Detector And Alarm, Arrhythmia

All 99
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K832354.
ARRHYTHMIA CENTRAL OCC-7101
K843287 · Nihon Kohden America, Inc. · Oct 1984
LIFESCOPE 6 OEC-6201
K841500 · Nihon Kohden America, Inc. · Aug 1984
LEAP FROG
K834211 · Philips Medical Systems (Cleveland), Inc. · Jun 1984
WLECTROCARDIOGRAPH ECG-7204
K831274 · Nihon Kohden America, Inc. · Oct 1983
QUINTON Q2000 ETT MONITORING SYSTEM
K820438 · Quinton, Inc. · Apr 1982
ALGORITHM OF THE ARRHYTHMIA MON. SYS
K820477 · Hewlett-Packard Co. · Apr 1982