Cleared Traditional

K972991 - MONITOR ONE NDX

K972991 is the FDA 510(k) clearance for MONITOR ONE NDX by Qmed, Inc.. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 478-day FDA review.

K972991 · Qmed, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
478d
Days
Class 2
Risk

K972991 is an FDA 510(k) clearance for the MONITOR ONE NDX. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Qmed, Inc. (Sag Harbor, US). The FDA issued a Cleared decision on December 3, 1998 after a review of 478 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Qmed, Inc. devices

Submission Details

510(k) Number K972991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1997
Decision Date December 03, 1998
Days to Decision 478 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
353d slower than avg
Panel avg: 125d · This submission: 478d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 258
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K972991.
QUINTON Q-STRESS, MODEL 000483
K001492 · Quinton, Inc. · Aug 2000
GE MARQUETTE MEDICAL SYSTEMS PRUCKA CARDIOLAB CATH SYSTEM, VERSION 1.11
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MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPTION
K991786 · General Electric Medical Systems Information Techn · Nov 1999
M1765A ECG MANAGER
K974746 · Hewlett-Packard Co. · Mar 1998
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP6/100
K972746 · Alexander Mfg. Co. · Oct 1997
SIGNAL-AVERAGED HIGH RESOLUTION P WAVE ANALYSIS
K972199 · Marquette Electronics, Inc. · Sep 1997