Cleared Special

K001100 - BIOZ.COM HEMODYNAMIC MONITOR WITH BIOZ TECT SENSOR AND BIOZ TECT CABLE IMPEDANCE PLETHYSMOGRAPH

K001100 is an FDA 510(k) clearance for BIOZ.COM HEMODYNAMIC MONITOR WITH BIOZ ..., 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 30-day FDA review.

K001100 · Cardiodynamics International Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
30d
Days
Class 2
Risk

K001100 is an FDA 510(k) clearance for the BIOZ.COM HEMODYNAMIC MONITOR WITH BIOZ TECT SENSOR AND BIOZ TECT CABLE IMPEDA.... 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 May 5, 2000 after a review of 30 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.

View all Cardiodynamics International Corp. devices

FDA 510(k) Submission Details - K001100

510(k) Number K001100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2000
Decision Date May 05, 2000
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 125d · This submission: 30d
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 26
Devices cleared under the same product code (DSB) and FDA review panel - the closest regulatory comparables to K001100.
BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR
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K041434 · Analogic Corp. · Aug 2004
ICG MODULE
K010164 · General Electric Medical Systems Information Techn · Apr 2001
PERCUPUMP II WITH EDA
K974621 · E-Z-Em, Inc. · Jan 1998
BIOZ SYSTEM & BIOZ PORTABLE
K972320 · Cardiodynamics International Corp. · Sep 1997
D SERIES ELECTRODE
K970603 · Cmc Sense-It, Inc. · Apr 1997