Cleared Traditional

HOLTER SCREENING MONITOR HS-221 (K842462) - FDA 510(k) Clearance

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

K842462 · Advantage Medical Systems, Inc. · Cardiovascular device
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Sep 1984
Decision
81d
Days
Class 2
Risk

K842462 is an FDA 510(k) clearance for the HOLTER SCREENING MONITOR HS-221. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Advantage Medical Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 11, 1984 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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 Advantage Medical Systems, Inc. devices

Submission Details

510(k) Number K842462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1984
Decision Date September 11, 1984
Days to Decision 81 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 125d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

All 73
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K842462.
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K844187 · Siemens Medical Solutions USA, Inc. · Apr 1985
PATIENT MONITOR 78354A
K842236 · Hewlett-Packard Co. · Jan 1985
ARRHYTHMIA CENTRAL-OGP-7201
K844911 · Nihon Kohden America, Inc. · Jan 1985
LIFESCOPE II
K841499 · Nihon Kohden America, Inc. · Aug 1984
LIFESCOPE 6 OEC-6102
K841501 · Nihon Kohden America, Inc. · Aug 1984
LIFESCOPE 6 OEC-6105
K841502 · Nihon Kohden America, Inc. · Aug 1984