Cleared Traditional

K842462 - HOLTER SCREENING MONITOR HS-221

K842462 is an FDA 510(k) clearance for HOLTER SCREENING MONITOR HS-221, manufactured by Advantage Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K842462 · Advantage Medical Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K842462

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.

DRT Device Classification - Class 2, Special Controls

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 173
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K842462.
SERVOMED BASIC BEDSIDE UNIT SMV 110TP
K840524 · Litton Medical Electronics · Oct 1984
HEART RATE/RESPIRATION SIMULATOR 8310
K841363 · Aequitron Medical, Inc. · Oct 1984
SERVOMED OXCARDIORE SPIROGRAPH 324/111
K840832 · Litton Medical Electronics · Sep 1984
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