Cleared Traditional

K051228 - BIOZDX HEMODYNAMIC MONITOR AND 12-LEAD ECG

K051228 is an FDA 510(k) clearance for BIOZDX HEMODYNAMIC MONITOR AND 12-LEAD ECG, 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 28-day FDA review.

K051228 · Cardiodynamics International Corp. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
28d
Days
Class 2
Risk

K051228 is an FDA 510(k) clearance for the BIOZDX HEMODYNAMIC MONITOR AND 12-LEAD ECG. 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 10, 2005 after a review of 28 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 - K051228

510(k) Number K051228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2005
Decision Date June 10, 2005
Days to Decision 28 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
97d faster than avg
Panel avg: 125d · This submission: 28d
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 K051228.
CHEETAH RELIANT, CHEETAH ACTIVE
K072662 · Cheetah Medical, Inc. · Jan 2008
BIOZ DX HEMODYNAMIC MONITOR WITH PHILIPS 12-LEAD ECG, MODEL 5100
K070156 · Cardiodynamics International Corp. · Sep 2007
BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM, MODEL NICAS 2004 SLIM
K070500 · Ni Medical · Jul 2007
BIOZDX HEMODYNAMIC MONITOR
K041294 · Cardiodynamics International Corp. · Dec 2004
ZOE FLUID STATUS MONITOR
K042113 · Noninvasive Medical Technologies, LLC · Sep 2004
C3 AND LIFEGARD ICG IMPEDANCE CARDIOGRAPHY MONITORS
K041434 · Analogic Corp. · Aug 2004
K051228 · BIOZDX HEMODYNAMIC MONITOR AND 12-LEAD ECG
Download PDF FDA Summary Cardiodynamics Intern…