Cleared Traditional

K110603 - HYPERTENSION MANAGEMENT SOFTWARE CLAIEN...

K110603 is the FDA 510(k) clearance for HYPERTENSION MANAGEMENT SOFTWARE CLAIEN... by I.E.M. GmbH. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 288-day FDA review.

K110603 · I.E.M. GmbH · Cardiovascular device
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Dec 2011
Decision
288d
Days
Class 2
Risk

K110603 is an FDA 510(k) clearance for the HYPERTENSION MANAGEMENT SOFTWARE CLAIENT SERVER (HMS-CS). Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by I.E.M. GmbH (Stolberg, DE). The FDA issued a Cleared decision on December 16, 2011 after a review of 288 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - 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 I.E.M. GmbH devices

Submission Details

510(k) Number K110603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2011
Decision Date December 16, 2011
Days to Decision 288 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
163d slower than avg
Panel avg: 125d · This submission: 288d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
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 - DXN System, Measurement, Blood-pressure, Non-invasive

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