510(k) · Cleared

Cleared

Bioz DX Hemodynamic Monitor with Philips 12-Lead Ecg, Model 5100

K070156510(k) TraditionalCleared Sep 26, 2007252-day reviewClass II21 CFR 870.2770

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cardiodynamics International Corp. · DSB Plethysmograph, Impedance

Cleared on Sep 26, 2007 as substantially equivalent to K051228 (Cardiodynamics International Corp., 2005) and 3 other predicates after a 252-day review. Its family tree reaches back 4 generations to 1990. 4 later devices descend from it.

Decided: Sep 26, 2007
Review: 252 days
Class: Class II
Product code: DSB
Recalls: None
Predicates: 4

Its longest line of descent runs back 4 generations to K895520 (1990). 13 ancestors in all. 4 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 4 generations backK895520 Pagewriter Xli M1700A & Pagewriter XL M1701AHewlett-Packard Co. · 1990
3 generations backK020708 Philips Pagewriter Touch Cardiograph, Model M5000A SeriesPhilips Medical Systems, Inc. · 2002 · Recalled
2 generations backK031422 Philips Page Writer Trim Series Cardiograph Including I, II, Iii…Philips Medical Systems · 2003
1 generation backK051228 Biozdx Hemodynamic Monitor and 12-Lead EcgCardiodynamics International Corp. · 2005
This deviceK070156 Bioz DX Hemodynamic Monitor with Philips 12-Lead Ecg, Model 5100Cardiodynamics International Corp. · 2007
Descendant · cites it directly · 1 of its ownK090602 Cardiodynamics Bioz RX, Model 7101-SysCardiodynamics International Corp. · 2009
Descendant · cites it directly · 0 of its ownK160899 CoVa Monitoring System 2Tosense, Inc. · 2017
Descendant · 2 generations on · 0 of its ownK110645 Bio Z Cardio Profile Hemodynamic MonitorSonosite,Inc. · 2011
Descendant · cites it directly · 0 of its ownK080941 Bioimpedance Cardiac Analyzing Measuring SystemN.I. Medical, Ltd. · 2009

Most influential descendants

Showing 4 of 4 · See all

K090602Cardiodynamics Bioz RX, Model 7101-SysCardiodynamics International Corp. · 2009 · cites it directly1descendant
K160899CoVa Monitoring System 2Tosense, Inc. · 2017 · cites it directly0descendants
K110645Bio Z Cardio Profile Hemodynamic MonitorSonosite,Inc. · 2011 · 2 generations on0descendants
K080941Bioimpedance Cardiac Analyzing Measuring SystemN.I. Medical, Ltd. · 2009 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K895520	Pagewriter Xli M1700A & Pagewriter XL M1701A	Hewlett-Packard Co.	1990	—
−3	K020708	Philips Pagewriter Touch Cardiograph, Model M5000A Series	Philips Medical Systems, Inc.	2002	2
−2	K031422	Philips Page Writer Trim Series Cardiograph Including I, II, Iii, Models…	Philips Medical Systems	2003	—
−1	K051228	Biozdx Hemodynamic Monitor and 12-Lead Ecg	Cardiodynamics International Corp.	2005	—
0 (this device)	K070156	Bioz DX Hemodynamic Monitor with Philips 12-Lead Ecg, Model 5100	Cardiodynamics International Corp.	2007	—
+1	K090602	Cardiodynamics Bioz RX, Model 7101-Sys	Cardiodynamics International Corp.	2009	—
+1	K160899	CoVa Monitoring System 2	Tosense, Inc.	2017	—
+2	K110645	Bio Z Cardio Profile Hemodynamic Monitor	Sonosite,Inc.	2011	—
+1	K080941	Bioimpedance Cardiac Analyzing Measuring System	N.I. Medical, Ltd.	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1997	1	0
1998	1	0
2000	1	0
2001	2	0
2003	1	0
2004	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	2	0
2011	1	0
2017	1	0

FIG. 1 — Lineage of K070156, 1990–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DSB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DSB device

#1 K232089 SOZO Proscore 14.6 · 9 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (4)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K051228	Biozdx Hemodynamic Monitor and 12-Lead Ecg Summary page 1 …858-535-0294 Paul L. Shaffer Director, Quality and Regulatory Date of Summary Preparation: January 15, 2007 SUBSTANTIAL EQUIVALENCE: Predicate Devices: K051228 - CardioDynamics BioZ® Dx Hemodynamic Monitor with Philips 12-Lead ECG K01 1439 - CardioDynamics BioZ®.com Hemodynamic Monitor…	Cardiodynamics International Corp.	2005	—
*	K011439	Modification to Bioz.Com Hemodynamic Monitor Summary page 1 …Summary Preparation: January 15, 2007 SUBSTANTIAL EQUIVALENCE: Predicate Devices: K051228 - CardioDynamics BioZ® Dx Hemodynamic Monitor with Philips 12-Lead ECG K01 1439 - CardioDynamics BioZ®.com Hemodynamic Monitor (for additional parameters) K041434 - Analogic C3 TM ICG Monitor (for additiona…	Cardiodynamics International Corp.	2001	—
*	K041434	C3 and Lifegard Icg Impedance Cardiography Monitors Summary page 1 …K051228 - CardioDynamics BioZ® Dx Hemodynamic Monitor with Philips 12-Lead ECG K01 1439 - CardioDynamics BioZ®.com Hemodynamic Monitor (for additional parameters) K041434 - Analogic C3 TM ICG Monitor (for additional parameters) K010164 - GE Medical Systems ICG Module (for additional parameters)…	Analogic Corp.	2004	—
*	K010164	Icg Module Summary page 1 …2-Lead ECG K01 1439 - CardioDynamics BioZ®.com Hemodynamic Monitor (for additional parameters) K041434 - Analogic C3 TM ICG Monitor (for additional parameters) K010164 - GE Medical Systems ICG Module (for additional parameters) Device Description: This submission covers Version 4.0b5 of the B…	General Electric Medical Systems Information Techn	2001	—

Also cleared against K051228: 1 other device →

What descends from it? (4)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K090602	Cardiodynamics Bioz RX, Model 7101-Sys	Cardiodynamics International Corp.	2009	1
K160899	CoVa Monitoring System 2	Tosense, Inc.	2017	0
K080941	Bioimpedance Cardiac Analyzing Measuring System	N.I. Medical, Ltd.	2009	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
1 of the 13 ancestors has a recall of any class.
Of its descendants, K090602 (Cardiodynamics International Corp., 2009) has gone furthest, with 1 descendant of its own.
1 other device also cites its predicate K051228.

How does its category compare?

All DSB devices

DSB Plethysmograph, Impedance: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · DSB

3in 2025

2007high 6 (2008) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DSB

266in 2025

2007high 266 (2025) · low 90 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DSB

1in 2015

2007high 1 (2015) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DSB

2in 2025

2007high 2 (2025) · low 0 (2007)2025

MAUDE reports naming product code DSB, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	2	—	0	0
2008	6	90	0	0
2009	2	—	0	0
2010	1	—	0	0
2011	2	—	0	0
2012	1	—	0	0
2013	2	—	0	0
2014	2	—	0	0
2015	2	—	1	0
2016	0	—	0	1
2017	2	—	0	0
2018	1	—	0	0
2019	1	—	0	0
2020	2	—	0	0
2021	1	—	0	0
2022	1	—	0	0
2023	2	—	0	0
2024	0	—	0	0
2025	3	266	0	2
2026	1	—	0	—

What is it indicated for?

For the lOG function: The BioZ Dx Hemodynamic Monitor is intended to monitor and display a patient's hemodynamic parameters. These parameters include: Heart Rate (HR) Thoracic Fluid Content Index (TFCI) Systolic Blood Pressure (SBP) Systolic Time Ratio (STR) Diastolic Blood Pressure (DBP) Systolic Time Ratio Index (STRI) Mean Arterial Blood Pressure (MAP) Pre-Ejection Period (PEP) Stroke Index (SI) Left Ventricular Ejection Time (LVET) Stroke Volume (SV)…

Read the full statement (185 words)

For the lOG function:

The BioZ Dx Hemodynamic Monitor is intended to monitor and display a patient's hemodynamic parameters. These parameters include:

Heart Rate (HR) Thoracic Fluid Content Index (TFCI)

Systolic Blood Pressure (SBP) Systolic Time Ratio (STR)

Diastolic Blood Pressure (DBP) Systolic Time Ratio Index (STRI)

Mean Arterial Blood Pressure (MAP) Pre-Ejection Period (PEP)

Stroke Index (SI) Left Ventricular Ejection Time (LVET)

Stroke Volume (SV) Total Arterial Compliance (TAC)

Cardiac Index (Cl) Total Arterial Compliance Index (TACI)

Cardiac Output (CO) Left Stroke Work Index (LSWI)

Systemic Vascular Resistance (SVR) Heather Index (HI)

Systemic Vascular Resistance Index (SVRI) Q -C Interval (QC)

Left Cardiac Work (LCW) Left Cardiac Work Index (LCWI)

Acceleration Index (ACl) Electrocardiograph (ECG)

Velocity Index or Index of Contractility (VI, IC) Systemic Stroke Resistance Index (SSRI or SSVRI)

Thoracic Fluid Content (TFC) End Diastolic Volume (EDV)

Base Impedance (TFI or Z0) End Diastolic Index (EDI)

For the optional 12-lead ECG function:

Where the clinician decides to evaluate the electrocardiogram of adult and pediatric patients as part of decisions regarding possible diagnosis, potential treatment, effectiveness of treatment or to rule-out causes for symptoms.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K070156 · printed Nov 4, 2026

Cite this page

510(k) Report. “K070156: Bioz DX Hemodynamic Monitor with Philips 12-Lead Ecg, Model 5100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070156

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026