510(k) · Cleared
ClearedBiozdx Hemodynamic Monitor
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 Dec 8, 2004 as substantially equivalent to K001081 (Cardiodynamics International Corp., 2000) and 1 other predicate after a 208-day review. Its family tree reaches back 2 generations to 1997. 9 later devices descend from it.
- Decided
- Dec 8, 2004
- Review
- 208 days
- Class
- Class II
- Product code
- DSB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K972320 (1997). 3 ancestors in all. 9 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK972320 Bioz System & Bioz PortableCardiodynamics International Corp. · 1997
- 1 generation backK974725 Bioz.Com SystemCardiodynamics International Corp. · 1998
- This deviceK041294 Biozdx Hemodynamic MonitorCardiodynamics International Corp. · 2004
- Descendant · cites it directly · 5 of its ownK051228 Biozdx Hemodynamic Monitor and 12-Lead EcgCardiodynamics International Corp. · 2005
- Descendant · 2 generations on · 4 of its ownK070156 Bioz DX Hemodynamic Monitor with Philips 12-Lead Ecg, Model 5100Cardiodynamics International Corp. · 2007
- Descendant · cites it directly · 2 of its ownK073280 Beneview T Series Patient Monitors, Models T8, T6 and T5Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- Descendant · 2 generations on · 1 of its ownK110922 Patient MonitorEdan Instruments, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 1 of its ownK090602 Cardiodynamics Bioz RX, Model 7101-SysCardiodynamics International Corp. · 2009
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K051228Biozdx Hemodynamic Monitor and 12-Lead EcgCardiodynamics International Corp. · 2005 · cites it directly5descendants
- K070156Bioz DX Hemodynamic Monitor with Philips 12-Lead Ecg, Model 5100Cardiodynamics International Corp. · 2007 · 2 generations on4descendants
- K073280Beneview T Series Patient Monitors, Models T8, T6 and T5Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008 · cites it directly2descendants
- K110922Patient MonitorEdan Instruments, Inc. · 2011 · 2 generations on1descendant
- K090602Cardiodynamics Bioz RX, Model 7101-SysCardiodynamics International Corp. · 2009 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K972320 | Bioz System & Bioz Portable | Cardiodynamics International Corp. | 1997 | — |
| −1 | K974725 | Bioz.Com System | Cardiodynamics International Corp. | 1998 | — |
| 0 (this device) | K041294 | Biozdx Hemodynamic Monitor | Cardiodynamics International Corp. | 2004 | — |
| +1 | K051228 | Biozdx Hemodynamic Monitor and 12-Lead Ecg | Cardiodynamics International Corp. | 2005 | — |
| +2 | K070156 | Bioz DX Hemodynamic Monitor with Philips 12-Lead Ecg, Model 5100 | Cardiodynamics International Corp. | 2007 | — |
| +1 | K073280 | Beneview T Series Patient Monitors, Models T8, T6 and T5 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| +2 | K110922 | Patient Monitor | Edan Instruments, Inc. | 2011 | 1 |
| +2 | K090602 | Cardiodynamics Bioz RX, Model 7101-Sys | Cardiodynamics International Corp. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K001081 | Bioz.PC Hemodynamic Monitor Model BZ-500/BZ-501; Bioz.PC User Software Installation Kit…Summary page 1…el: Part # BZ-500/501 Manufacturer: CardioDynamics International Corporation Predicate Device 510(k): K001081 on 6/31/2000 Reason for Submission: Repackaging and porting of functionality from an off-the-shelf PC… | 2000 |
| * | K974725 | Bioz.Com SystemSummary page 1…odel: Part # BZ-4110O Manufacturer: CardioDynamics International Corporation Predicate Device 510(k): K974725 on 3/18/1998 Reason for Submission: Repackaging and porting of functionality from an embedded PC… | 1998 |
| † | K031422 | Philips Page Writer Trim Series Cardiograph Including I, II, Iii, Models 860286, 860287… | 2003 |
| † | K011797 | Bioztect Sensor and Bioztect Cable | 2001 |
What descends from it? (9)
3 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 7 years and passes through 1 company; a new generation was cleared every 6.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K051228 (Cardiodynamics International Corp., 2005) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K001081.
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
PressureLeft Cardiac Work
Diastolic Blood Pressure
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041294 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041294: Biozdx Hemodynamic Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041294
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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