510(k) · Cleared

Cleared

Cardiodynamics Bioz RX, Model 7101-Sys

K090602510(k) TraditionalCleared May 28, 200984-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 May 28, 2009 as substantially equivalent to K070156 (Cardiodynamics International Corp., 2007) and 3 other predicates after an 84-day review. Its family tree reaches back 5 generations to 1990. 1 later device descends from it.

Decided: May 28, 2009
Review: 84 days
Class: Class II
Product code: DSB
Recalls: None
Predicates: 4

Its longest line of descent runs back 5 generations to K895520 (1990). 18 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 5 generations backK895520 Pagewriter Xli M1700A & Pagewriter XL M1701AHewlett-Packard Co. · 1990
4 generations backK020708 Philips Pagewriter Touch Cardiograph, Model M5000A SeriesPhilips Medical Systems, Inc. · 2002 · Recalled
3 generations backK031422 Philips Page Writer Trim Series Cardiograph Including I, II, Iii…Philips Medical Systems · 2003
2 generations backK051228 Biozdx Hemodynamic Monitor and 12-Lead EcgCardiodynamics International Corp. · 2005
1 generation backK070156 Bioz DX Hemodynamic Monitor with Philips 12-Lead Ecg, Model 5100Cardiodynamics International Corp. · 2007
This deviceK090602 Cardiodynamics Bioz RX, Model 7101-SysCardiodynamics International Corp. · 2009
Descendant · cites it directly · 0 of its ownK110645 Bio Z Cardio Profile Hemodynamic MonitorSonosite,Inc. · 2011

Most influential descendants

Showing 1 of 1 · See all

K110645Bio Z Cardio Profile Hemodynamic MonitorSonosite,Inc. · 2011 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K895520	Pagewriter Xli M1700A & Pagewriter XL M1701A	Hewlett-Packard Co.	1990	—
−4	K020708	Philips Pagewriter Touch Cardiograph, Model M5000A Series	Philips Medical Systems, Inc.	2002	2
−3	K031422	Philips Page Writer Trim Series Cardiograph Including I, II, Iii, Models…	Philips Medical Systems	2003	—
−2	K051228	Biozdx Hemodynamic Monitor and 12-Lead Ecg	Cardiodynamics International Corp.	2005	—
−1	K070156	Bioz DX Hemodynamic Monitor with Philips 12-Lead Ecg, Model 5100	Cardiodynamics International Corp.	2007	—
0 (this device)	K090602	Cardiodynamics Bioz RX, Model 7101-Sys	Cardiodynamics International Corp.	2009	—
+1	K110645	Bio Z Cardio Profile Hemodynamic Monitor	Sonosite,Inc.	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	2	0
1997	2	0
1998	2	0
2000	1	0
2001	2	0
2003	1	0
2004	2	0
2005	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0

FIG. 1 — Lineage of K090602, 1990–2011Source: 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

Get a 510(k) Report

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
*	K070156	Bioz DX Hemodynamic Monitor with Philips 12-Lead Ecg, Model 5100 Summary page 1 …Fax: 866-581-9123 Donald J. Brooks Chief Technology Officer Date of Summary Preparation: February 27, 2009 SUBSTANTIAL EQUIVALENCE: Predicate Devices: K070156 - CardioDynamics BioZ® Dx 1-lemodynamic Monitor with 12-Lead ECG K051228 - CardioDynamics BioZ® Dx Hemodynamic Monitor and Ph…	Cardiodynamics International Corp.	2007	—
*	K051228	Biozdx Hemodynamic Monitor and 12-Lead Ecg Summary page 1 …of Summary Preparation: February 27, 2009 SUBSTANTIAL EQUIVALENCE: Predicate Devices: K070156 - CardioDynamics BioZ® Dx 1-lemodynamic Monitor with 12-Lead ECG K051228 - CardioDynamics BioZ® Dx Hemodynamic Monitor and Philips 12-Lead ECG K052158 - Welch/Allyn Cardioperfect Software with Acces…	Cardiodynamics International Corp.	2005	—
*	K052158	Welch Allyn Cardioperfect Workstation Version 1.5.0 Software Summary page 1 …vices: K070156 - CardioDynamics BioZ® Dx 1-lemodynamic Monitor with 12-Lead ECG K051228 - CardioDynamics BioZ® Dx Hemodynamic Monitor and Philips 12-Lead ECG K052158 - Welch/Allyn Cardioperfect Software with Accessories K962854 - Welch/Allyn Cardioperfect Portable Device Description: Th…	Welch Allyn, Inc.	2005	—
*	K962854	Hardware:Cardio Perfect Portable, Cardio Perfect MD and Software:Cardio Perfect (V. 4.0… Summary page 1 …with 12-Lead ECG K051228 - CardioDynamics BioZ® Dx Hemodynamic Monitor and Philips 12-Lead ECG K052158 - Welch/Allyn Cardioperfect Software with Accessories K962854 - Welch/Allyn Cardioperfect Portable Device Description: This submission for the BioZ Rx covers a PC platform/printer/cart ch…	Cardio Control BV	1997	—

Also cleared against K070156: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K110645	Bio Z Cardio Profile Hemodynamic Monitor	Sonosite,Inc.	2011	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 19 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
1 of the 18 ancestors has a recall of any class.
Of its descendants, K110645 (Sonosite,Inc., 2011) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K070156.

How does its category compare?

All DSB devices

DSB Plethysmograph, Impedance: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 ICG function: The BioZ Rx 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 (172 words)

For the ICG function:

The BioZ Rx 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 (CI) Total Arterial Compliance Index (TACI)

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

Systemic Vascular Resistance (SVR) Heather Index (RI)

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

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

Acceleration Index (ACI) Systemic Stroke Resistance Index (SSRI/SSVRI)

Velocity Index/Index of Contractility (VI, IC) Base Impedance (TFf or Z4)

Thoracic Fluid Content (TFC) Electrocardiogram (ECG)

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/K090602 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090602: Cardiodynamics Bioz RX, Model 7101-Sys.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090602

Report an extraction error

Are you the manufacturer?

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