Cleared Traditional

K911646 - NGM ESTP MODULE

K911646 is the FDA 510(k) clearance for NGM ESTP MODULE by Datex Division Instrumentarium Corp.. It is a Class 2 Cardiovascular device (product code MHX) cleared through the Traditional 510(k) pathway after a 312-day FDA review.

K911646 · Datex Division Instrumentarium Corp. · Cardiovascular device
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Feb 1992
Decision
312d
Days
Class 2
Risk

K911646 is an FDA 510(k) clearance for the NGM ESTP MODULE. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Datex Division Instrumentarium Corp. (Tewksbury, US). The FDA issued a Cleared decision on February 21, 1992 after a review of 312 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Datex Division Instrumentarium Corp. devices

Submission Details

510(k) Number K911646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1991
Decision Date February 21, 1992
Days to Decision 312 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
187d slower than avg
Panel avg: 125d · This submission: 312d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
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 - MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

All 199
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K911646.
PORTABLE PATIENT MONITOR
K922974 · Hewlett-Packard Co. · Dec 1992
MODELS M1175A AND M1176A COMPONENT MONITORING SYST
K922058 · Hewlett-Packard Co. · Oct 1992
MODEL M2350A AND M2360A WAVEVUE CENTRAL MONITOR
K921014 · Hewlett-Packard Co. · Oct 1992
MONARCH SYSTEM
K911051 · Baxter Healthcare Corp · Aug 1991