Cleared Special

K032491 - ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MO...

K032491 is an FDA 510(k) clearance for ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MO..., manufactured by Imagyn Medical Technologies, Inc.. The device is a Class 2 Cardiovascular device with product code DSB cleared through the Special 510(k) pathway after a 23-day FDA review.

K032491 · Imagyn Medical Technologies, Inc. · Cardiovascular device
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Sep 2003
Decision
23d
Days
Class 2
Risk

K032491 is an FDA 510(k) clearance for the ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR. Classified as Plethysmograph, Impedance (product code DSB), Class II - Special Controls.

Submitted by Imagyn Medical Technologies, Inc. (Irvine, US). The FDA issued a Cleared decision on September 4, 2003 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2770 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Imagyn Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K032491

510(k) Number K032491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received August 12, 2003
Decision Date September 04, 2003
Days to Decision 23 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 125d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

DSB Device Classification - Class 2, Special Controls

Product Code DSB Plethysmograph, Impedance
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2770
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 - DSB Plethysmograph, Impedance

All 17
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