Cleared Special

K011797 - BIOZTECT SENSOR AND BIOZTECT CABLE

K011797 is an FDA 510(k) clearance for BIOZTECT SENSOR AND BIOZTECT CABLE, manufactured by Cardiodynamics International Corp.. The device is a Class 2 Cardiovascular device with product code DSB cleared through the Special 510(k) pathway after a 25-day FDA review.

K011797 · Cardiodynamics International Corp. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
25d
Days
Class 2
Risk

K011797 is an FDA 510(k) clearance for the BIOZTECT SENSOR AND BIOZTECT CABLE. 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 July 3, 2001 after a review of 25 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 - K011797

510(k) Number K011797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2001
Decision Date July 03, 2001
Days to Decision 25 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
100d faster than avg
Panel avg: 125d · This submission: 25d
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 81
Devices cleared under the same product code (DSB) and FDA review panel - the closest regulatory comparables to K011797.
TASK FORCE MONITOR 3040
K014063 · Cnsystems Medizintechnik GmbH · Feb 2002
SORBA STEORRA NON-INVASIVE IMPEDANCE CARDIOGRAPH
K014299 · Sorba Medical Systems, Inc. · Jan 2002
MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITOR
K011439 · Cardiodynamics International Corp. · Nov 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
BIOZ.COM HEMODYNAMIC MONITOR WITH BIOZ TECT SENSOR AND BIOZ TECT CABLE IMPEDANCE PLETHYSMOGRAPH
K001100 · Cardiodynamics International Corp. · May 2000
K011797 · BIOZTECT SENSOR AND BIOZTECT CABLE
Download PDF FDA Summary Cardiodynamics Intern…