Cleared Traditional

K001081 - BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501

Also marketed or referenced as:
BIOZ.PC USER SOFTWARE INSTALLATION KIT MODEL BZ-810

K001081 is an FDA 510(k) clearance for BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-50..., 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 87-day FDA review.

K001081 · Cardiodynamics International Corp. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
87d
Days
Class 2
Risk

K001081 is an FDA 510(k) clearance for the BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501. 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 June 30, 2000 after a review of 87 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K001081

510(k) Number K001081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2000
Decision Date June 30, 2000
Days to Decision 87 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
38d faster than avg
Panel avg: 125d · This submission: 87d
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 K001081.
MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITOR
K011439 · Cardiodynamics International Corp. · Nov 2001
BIOZTECT SENSOR AND BIOZTECT CABLE
K011797 · Cardiodynamics International Corp. · Jul 2001
ICG MODULE
K010164 · General Electric Medical Systems Information Techn · Apr 2001
BIOZ.COM HEMODYNAMIC MONITOR WITH BIOZ TECT SENSOR AND BIOZ TECT CABLE IMPEDANCE PLETHYSMOGRAPH
K001100 · Cardiodynamics International Corp. · May 2000
IQ SYSTEM
K981720 · Renaissance Technology, Inc. · Feb 1999
BIOZ.COM SYSTEM
K974725 · Cardiodynamics International Corp. · Mar 1998
K001081 · BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501
Download PDF FDA Summary Cardiodynamics Intern…