Cleared Special

K133301 - ZOE FLUID STATUS MONITOR

K133301 is an FDA 510(k) clearance for ZOE FLUID STATUS MONITOR, manufactured by Noninvasive Medical Technologies, Inc.. The device is a Class 2 Cardiovascular device with product code DSB cleared through the Special 510(k) pathway after a 89-day FDA review.

K133301 · Noninvasive Medical Technologies, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2014
Decision
89d
Days
Class 2
Risk

K133301 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, Inc. (Las Vegas, US). The FDA issued a Cleared decision on January 22, 2014 after a review of 89 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 - K133301

510(k) Number K133301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2013
Decision Date January 22, 2014
Days to Decision 89 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
36d faster than avg
Panel avg: 125d · This submission: 89d
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 75
Devices cleared under the same product code (DSB) and FDA review panel - the closest regulatory comparables to K133301.
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K150095 · Sensible Medical Innovations , Ltd. · Aug 2015
IMED-Z FLUID STATUS MONITOR
K142503 · Intersection Medical, Inc. · Jun 2015
PHYSIOFLOW Q-LINK
K140102 · Vasocom, Inc. · Feb 2014
ECOM ENDOTRACHEAL CARDIAC OUTPUT MONITOR SYSTEM
K131765 · Conmed Corporation · Dec 2013
ZOE FLUID STATUS MONITOR
K131509 · Noninvasive Medical Technologies, Inc. · Jun 2013
ZOEFLUID STATUS MONITOR (MODEL ZOE 2B)
K112830 · Noninvasive Medical Technologies, Inc. · Nov 2012
K133301 · ZOE FLUID STATUS MONITOR
Download PDF FDA Summary Noninvasive Medical T…