Cleared Traditional

K131765 - ECOM ENDOTRACHEAL CARDIAC OUTPUT MONITOR SYSTEM

K131765 is an FDA 510(k) clearance for ECOM ENDOTRACHEAL CARDIAC OUTPUT MONITO..., manufactured by Conmed Corporation. The device is a Class 2 Cardiovascular device with product code DSB cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K131765 · Conmed Corporation · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2013
Decision
186d
Days
Class 2
Risk

K131765 is an FDA 510(k) clearance for the ECOM ENDOTRACHEAL CARDIAC OUTPUT MONITOR SYSTEM. Classified as Plethysmograph, Impedance (product code DSB), Class II - Special Controls.

Submitted by Conmed Corporation (Utica, US). The FDA issued a Cleared decision on December 20, 2013 after a review of 186 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2770 - 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.

FDA 510(k) Submission Details - K131765

510(k) Number K131765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2013
Decision Date December 20, 2013
Days to Decision 186 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
61d slower than avg
Panel avg: 125d · This submission: 186d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 82
Devices cleared under the same product code (DSB) and FDA review panel - the closest regulatory comparables to K131765.
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BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR
K110645 · Sonosite,Inc. · Jun 2011
K131765 · ECOM ENDOTRACHEAL CARDIAC OUTPUT MONITOR SYSTEM
Download PDF FDA Summary Conmed Corporation