Cleared Traditional

K112830 - ZOEFLUID STATUS MONITOR (MODEL ZOE 2B)

K112830 is an FDA 510(k) clearance for ZOEFLUID STATUS MONITOR (MODEL ZOE 2B), manufactured by Noninvasive Medical Technologies, Inc.. The device is a Class 2 Cardiovascular device with product code DSB cleared through the Traditional 510(k) pathway after a 412-day FDA review.

K112830 · Noninvasive Medical Technologies, Inc. · Cardiovascular device
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Nov 2012
Decision
412d
Days
Class 2
Risk

K112830 is an FDA 510(k) clearance for the ZOEFLUID STATUS MONITOR (MODEL ZOE 2B). 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 November 13, 2012 after a review of 412 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Noninvasive Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K112830

510(k) Number K112830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2011
Decision Date November 13, 2012
Days to Decision 412 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
287d slower than avg
Panel avg: 125d · This submission: 412d
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
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