Cleared Traditional

K173895 - Tel-O-Graph

K173895 is the FDA 510(k) clearance for Tel-O-Graph by I.E.M. Industrielle Entwicklung and Medizintechnik. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 511-day FDA review.

K173895 · I.E.M. Industrielle Entwicklung and Medizintechnik · Cardiovascular device
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May 2019
Decision
511d
Days
Class 2
Risk

K173895 is an FDA 510(k) clearance for the Tel-O-Graph. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by I.E.M. Industrielle Entwicklung and Medizintechnik (Stolberg, DE). The FDA issued a Cleared decision on May 16, 2019 after a review of 511 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 I.E.M. Industrielle Entwicklung and Medizintechnik devices

Submission Details

510(k) Number K173895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2017
Decision Date May 16, 2019
Days to Decision 511 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
386d slower than avg
Panel avg: 125d · This submission: 511d
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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