Cleared Traditional

K945138 - OMEGA 5600 SERIES NON-INVASIVE BLOOD PRESSURE MONITORS

K945138 is an FDA 510(k) clearance for OMEGA 5600 SERIES NON-INVASIVE BLOOD PR..., manufactured by Invivo Research, Inc.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 396-day FDA review.

K945138 · Invivo Research, Inc. · Cardiovascular device
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Nov 1995
Decision
396d
Days
Class 2
Risk

K945138 is an FDA 510(k) clearance for the OMEGA 5600 SERIES NON-INVASIVE BLOOD PRESSURE MONITORS. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Invivo Research, Inc. (Orlando, US). The FDA issued a Cleared decision on November 20, 1995 after a review of 396 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: 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.

FDA 510(k) Submission Details - K945138

510(k) Number K945138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1994
Decision Date November 20, 1995
Days to Decision 396 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
271d slower than avg
Panel avg: 125d · This submission: 396d
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 1068
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K945138.
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K953472 · Nellcor, Inc. · Oct 1995
ANEROID SPHYGMOMANOMETERS/MERCURIAL SPHYGMOMANOMETERSRS
K942543 · Sankei Co., Ltd. · Jul 1995
K945138 · OMEGA 5600 SERIES NON-INVASIVE BLOOD PRESSURE MONITORS
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