Cleared Traditional

K011439 - MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITOR

K011439 is an FDA 510(k) clearance for MODIFICATION TO BIOZ.COM HEMODYNAMIC MO..., 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 176-day FDA review.

K011439 · Cardiodynamics International Corp. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2001
Decision
176d
Days
Class 2
Risk

K011439 is an FDA 510(k) clearance for the MODIFICATION TO BIOZ.COM 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 November 2, 2001 after a review of 176 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 - K011439

510(k) Number K011439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2001
Decision Date November 02, 2001
Days to Decision 176 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
51d slower than avg
Panel avg: 125d · This submission: 176d
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 K011439.
ECOM ENDOTRACHIAL CARDIAC OUTPUT MONITOR
K021174 · Imagyn Surgical · Apr 2003
TASK FORCE MONITOR 3040
K014063 · Cnsystems Medizintechnik GmbH · Feb 2002
SORBA STEORRA NON-INVASIVE IMPEDANCE CARDIOGRAPH
K014299 · Sorba Medical Systems, Inc. · Jan 2002
BIOZTECT SENSOR AND BIOZTECT CABLE
K011797 · Cardiodynamics International Corp. · Jul 2001
ICG MODULE
K010164 · General Electric Medical Systems Information Techn · Apr 2001
BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501
K001081 · Cardiodynamics International Corp. · Jun 2000
K011439 · MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITOR
Download PDF FDA Summary Cardiodynamics Intern…