Cleared Traditional

K974725 - BIOZ.COM SYSTEM

K974725 is an FDA 510(k) clearance for BIOZ.COM SYSTEM, 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 90-day FDA review.

K974725 · Cardiodynamics International Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
90d
Days
Class 2
Risk

K974725 is an FDA 510(k) clearance for the BIOZ.COM SYSTEM. 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 March 18, 1998 after a review of 90 days - within the typical 510(k) review window.

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.

View all Cardiodynamics International Corp. devices

FDA 510(k) Submission Details - K974725

510(k) Number K974725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1997
Decision Date March 18, 1998
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
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 26
Devices cleared under the same product code (DSB) and FDA review panel - the closest regulatory comparables to K974725.
BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR
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C3 AND LIFEGARD ICG IMPEDANCE CARDIOGRAPHY MONITORS
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