Cleared Traditional

K841172 - MONITOR ONE

K841172 is an FDA 510(k) clearance for MONITOR ONE, manufactured by Qmed, Inc.. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K841172 · Qmed, Inc. · Cardiovascular device
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Jul 1984
Decision
130d
Days
Class 2
Risk

K841172 is an FDA 510(k) clearance for the MONITOR ONE. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Qmed, Inc. (Clark, US). The FDA issued a Cleared decision on July 27, 1984 after a review of 130 days - within the typical 510(k) review window.

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 Qmed, Inc. devices

FDA 510(k) Submission Details - K841172

510(k) Number K841172 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1984
Decision Date July 27, 1984
Days to Decision 130 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 125d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSI Device Classification - Class 2, Special Controls

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 300
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K841172.
ARRHYTHMIA CENTRAL OCC-7101
K843287 · Nihon Kohden America, Inc. · Oct 1984
SPACELABS ICR ARRHYTHMIA MASTER I HOLTER
K842640 · Spacelabs, Inc. · Oct 1984
LIFESCOPE 6 OEC-6201
K841500 · Nihon Kohden America, Inc. · Aug 1984
CARDIO EXPRESS 100 HOLTER SCANNER
K840622 · Del Mar Avionics · Jul 1984
LEAP FROG
K834211 · Philips Medical Systems (Cleveland), Inc. · Jun 1984
ALPHA MASS STORAGE CARDULE 1895
K834597 · Spacelabs, Inc. · Apr 1984