Cleared Special

K042113 - ZOE FLUID STATUS MONITOR

K042113 is an FDA 510(k) clearance for ZOE FLUID STATUS MONITOR, manufactured by Noninvasive Medical Technologies, LLC. The device is a Class 2 Cardiovascular device with product code DSB cleared through the Special 510(k) pathway after a 40-day FDA review.

K042113 · Noninvasive Medical Technologies, LLC · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2004
Decision
40d
Days
Class 2
Risk

K042113 is an FDA 510(k) clearance for the ZOE FLUID STATUS MONITOR. Classified as Plethysmograph, Impedance (product code DSB), Class II - Special Controls.

Submitted by Noninvasive Medical Technologies, LLC (Carlsbad, US). The FDA issued a Cleared decision on September 14, 2004 after a review of 40 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.

FDA 510(k) Submission Details - K042113

510(k) Number K042113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2004
Decision Date September 14, 2004
Days to Decision 40 days
Submission Type Special
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
85d faster than avg
Panel avg: 125d · This submission: 40d
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 113
Devices cleared under the same product code (DSB) and FDA review panel - the closest regulatory comparables to K042113.
BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM, MODEL NICAS 2004 SLIM
K070500 · Ni Medical · Jul 2007
BIOZDX HEMODYNAMIC MONITOR AND 12-LEAD ECG
K051228 · Cardiodynamics International Corp. · Jun 2005
BIOZDX HEMODYNAMIC MONITOR
K041294 · Cardiodynamics International Corp. · Dec 2004
C3 AND LIFEGARD ICG IMPEDANCE CARDIOGRAPHY MONITORS
K041434 · Analogic Corp. · Aug 2004
ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR
K032491 · Imagyn Medical Technologies, Inc. · Sep 2003
ECOM ENDOTRACHIAL CARDIAC OUTPUT MONITOR
K021174 · Imagyn Surgical · Apr 2003
K042113 · ZOE FLUID STATUS MONITOR
Download PDF FDA Summary Noninvasive Medical T…