Cleared Traditional

K172196 - ECOM Cardiac Output Monitoring System

K172196 is an FDA 510(k) clearance for ECOM Cardiac Output Monitoring System, manufactured by Ecom Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DSB cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K172196 · Ecom Medical, Inc. · Cardiovascular device
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Sep 2017
Decision
60d
Days
Class 2
Risk

K172196 is an FDA 510(k) clearance for the ECOM™ Cardiac Output Monitoring System. Classified as Plethysmograph, Impedance (product code DSB), Class II - Special Controls.

Submitted by Ecom Medical, Inc. (San Juan Capistrano, US). The FDA issued a Cleared decision on September 19, 2017 after a review of 60 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. 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 Ecom Medical, Inc. devices

FDA 510(k) Submission Details - K172196

510(k) Number K172196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2017
Decision Date September 19, 2017
Days to Decision 60 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 125d · This submission: 60d
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 22
Devices cleared under the same product code (DSB) and FDA review panel - the closest regulatory comparables to K172196.
Cardiac Monitor 1500
K191697 · Zynex Medical, Inc. · Feb 2020
ReDS System
K180479 · Sensible Medical Innovations , Ltd. · Feb 2019
Cardiovascular Analzyer
K172431 · Physiowave, Inc. · Mar 2018
ECOM ENDOTRACHEAL CARDIAC OUTPUT MONITOR SYSTEM
K131765 · Conmed Corporation · Dec 2013
BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR
K110645 · Sonosite,Inc. · Jun 2011
C3 AND LIFEGARD ICG IMPEDANCE CARDIOGRAPHY MONITORS
K041434 · Analogic Corp. · Aug 2004