Cleared Traditional

K191697 - Cardiac Monitor 1500

K191697 is an FDA 510(k) clearance for Cardiac Monitor 1500, manufactured by Zynex Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DSB cleared through the Traditional 510(k) pathway after a 241-day FDA review.

K191697 · Zynex Medical, Inc. · Cardiovascular device
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Feb 2020
Decision
241d
Days
Class 2
Risk

K191697 is an FDA 510(k) clearance for the Cardiac Monitor 1500. Classified as Plethysmograph, Impedance (product code DSB), Class II - Special Controls.

Submitted by Zynex Medical, Inc. (Englewood, US). The FDA issued a Cleared decision on February 21, 2020 after a review of 241 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.

View all Zynex Medical, Inc. devices

FDA 510(k) Submission Details - K191697

510(k) Number K191697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2019
Decision Date February 21, 2020
Days to Decision 241 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
116d slower than avg
Panel avg: 125d · This submission: 241d
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 17
Devices cleared under the same product code (DSB) and FDA review panel - the closest regulatory comparables to K191697.
Bodyport Cardiac Scale
K211585 · Bodyport, Inc. · Jul 2022
SOZO
K203473 · ImpediMed Limited · Apr 2021
SOZO Body Fluid Analyzer
K193410 · ImpediMed Limited · Oct 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