Cleared Traditional

K041313 - STABIL-O-GRAPH

K041313 is an FDA 510(k) clearance for STABIL-O-GRAPH, manufactured by I.E.M. GmbH. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K041313 · I.E.M. GmbH · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jun 2004
Decision
32d
Days
Class 2
Risk

K041313 is an FDA 510(k) clearance for the STABIL-O-GRAPH. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by I.E.M. GmbH (Bonita Springs, US). The FDA issued a Cleared decision on June 18, 2004 after a review of 32 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all I.E.M. GmbH devices

FDA 510(k) Submission Details - K041313

510(k) Number K041313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2004
Decision Date June 18, 2004
Days to Decision 32 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
93d faster than avg
Panel avg: 125d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXN Device Classification - Class 2, Special Controls

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

All 844
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