Cleared Traditional

K041294 - BIOZDX HEMODYNAMIC MONITOR

K041294 is an FDA 510(k) clearance for BIOZDX HEMODYNAMIC MONITOR, manufactured by Cardiodynamics International Corp.. The device is a Class 2 Cardiovascular device with product code DSB cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K041294 · Cardiodynamics International Corp. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2004
Decision
208d
Days
Class 2
Risk

K041294 is an FDA 510(k) clearance for the BIOZDX HEMODYNAMIC MONITOR. Classified as Plethysmograph, Impedance (product code DSB), Class II - Special Controls.

Submitted by Cardiodynamics International Corp. (San Diego, US). The FDA issued a Cleared decision on December 8, 2004 after a review of 208 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.

FDA 510(k) Submission Details - K041294

510(k) Number K041294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2004
Decision Date December 08, 2004
Days to Decision 208 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
83d slower than avg
Panel avg: 125d · This submission: 208d
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 81
Devices cleared under the same product code (DSB) and FDA review panel - the closest regulatory comparables to K041294.
BIOZ DX HEMODYNAMIC MONITOR WITH PHILIPS 12-LEAD ECG, MODEL 5100
K070156 · Cardiodynamics International Corp. · Sep 2007
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
ZOE FLUID STATUS MONITOR
K042113 · Noninvasive Medical Technologies, LLC · Sep 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
K041294 · BIOZDX HEMODYNAMIC MONITOR
Download PDF FDA Summary Cardiodynamics Intern…