510(k) · Cleared
ClearedBiozdx Hemodynamic Monitor and 12-Lead Ecg
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiodynamics International Corp. · DSB Plethysmograph, Impedance
Cleared on Jun 10, 2005 as substantially equivalent to K041294 (Cardiodynamics International Corp., 2004) and 1 other predicate after a 28-day review. Its family tree reaches back 3 generations to 1990. 5 later devices descend from it.
- Decided
- Jun 10, 2005
- Review
- 28 days
- Class
- Class II
- Product code
- DSB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K895520 (1990). 7 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK895520 Pagewriter Xli M1700A & Pagewriter XL M1701AHewlett-Packard Co. · 1990
- 2 generations backK020708 Philips Pagewriter Touch Cardiograph, Model M5000A SeriesPhilips Medical Systems, Inc. · 2002 · Recalled
- 1 generation backK031422 Philips Page Writer Trim Series Cardiograph Including I, II, Iii…Philips Medical Systems · 2003
- This deviceK051228 Biozdx Hemodynamic Monitor and 12-Lead EcgCardiodynamics International Corp. · 2005
- Descendant · cites it directly · 4 of its ownK070156 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 · 2 generations on · 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 · 2 generations on · 0 of its ownK080941 Bioimpedance Cardiac Analyzing Measuring SystemN.I. Medical, Ltd. · 2009
Most influential descendants
Showing 5 of 5 · See all- K070156Bioz DX Hemodynamic Monitor with Philips 12-Lead Ecg, Model 5100Cardiodynamics International Corp. · 2007 · cites it directly4descendants
- K090602Cardiodynamics Bioz RX, Model 7101-SysCardiodynamics International Corp. · 2009 · cites it directly1descendant
- K160899CoVa Monitoring System 2Tosense, Inc. · 2017 · 2 generations on0descendants
- K110645Bio Z Cardio Profile Hemodynamic MonitorSonosite,Inc. · 2011 · 2 generations on0descendants
- K080941Bioimpedance Cardiac Analyzing Measuring SystemN.I. Medical, Ltd. · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K895520 | Pagewriter Xli M1700A & Pagewriter XL M1701A | Hewlett-Packard Co. | 1990 | — |
| −2 | K020708 | Philips Pagewriter Touch Cardiograph, Model M5000A Series | Philips Medical Systems, Inc. | 2002 | 2 |
| −1 | K031422 | Philips Page Writer Trim Series Cardiograph Including I, II, Iii, Models… | Philips Medical Systems | 2003 | — |
| 0 (this device) | 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 | — |
| +1 | K090602 | Cardiodynamics Bioz RX, Model 7101-Sys | Cardiodynamics International Corp. | 2009 | — |
| +2 | K160899 | CoVa Monitoring System 2 | Tosense, Inc. | 2017 | — |
| +2 | K110645 | Bio Z Cardio Profile Hemodynamic Monitor | Sonosite,Inc. | 2011 | — |
| +2 | K080941 | Bioimpedance Cardiac Analyzing Measuring System | N.I. Medical, Ltd. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
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
What was it cleared against? (2)
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 | Decided |
|---|---|---|---|
| * | K041294 | Biozdx Hemodynamic MonitorSummary page 1…or Model 5100 Manufacturer: CardioDynamics International Corporation (CDIC) Predicate Device 510(k): K041294 on 12/6/04 Predicate device 2: Philips PageWriter Trim Cardiograph Model: Page… | 2004 |
| * | K031422 | Philips Page Writer Trim Series Cardiograph Including I, II, Iii, Models 860286, 860287…Summary page 1…h Model: PageWriter Trim III Manufacturer: Philips Medical Systems (Philips) Predicate Device 510(k): K031422 on 7/3/03 Reason for Submission: The new product is the combination of two individually 510(k)… | 2003 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 15 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K070156 (Cardiodynamics International Corp., 2007) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K041294.
How does its category compare?
All DSB devicesDSB Plethysmograph, Impedance: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DSB
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSB
266in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSB
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DSB
2in 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?
The BioZDx Hemodynamic Monitor is intended to monitor and display a patient's hemodynamic parameters. These parameters include: ECG Pre-Ejection Period Systolic Time Ratio Cardiac Output Heart Rate End diastolic Index Thoracic Fluid Content Acceleration Index Cardiac Index Left Vent. Ejection Time Index of Contractility End Diastolic Volume Mean Blood Pressure Stroke Volume Systemic Vascular Resistance Systolic Blood Pressure Left Cardiac Work Diastolic…
Read the full statement (95 words)
The BioZDx Hemodynamic Monitor is intended to monitor and display a patient's hemodynamic parameters. These parameters include:
ECG Pre-Ejection Period Systolic Time Ratio
Cardiac Output Heart Rate End diastolic Index
Thoracic Fluid Content Acceleration Index Cardiac Index
Left Vent. Ejection Time Index of Contractility
End Diastolic Volume Mean Blood Pressure Stroke Volume
Systemic Vascular Resistance Systolic Blood Pressure
Left Cardiac Work Diastolic Blood Pressure
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/K051228 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051228: Biozdx Hemodynamic Monitor and 12-Lead Ecg.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051228
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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