510(k) · Cleared
ClearedBioz.Com System
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 Mar 18, 1998 as substantially equivalent to K972320 (Cardiodynamics International Corp., 1997) after a 90-day review. Its family tree reaches back 1 generation to 1997. 19 later devices descend from it.
- Decided
- Mar 18, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- DSB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K972320 (1997). 19 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK972320 Bioz System & Bioz PortableCardiodynamics International Corp. · 1997
- This deviceK974725 Bioz.Com SystemCardiodynamics International Corp. · 1998
- Descendant · cites it directly · 11 of its ownK041434 C3 and Lifegard Icg Impedance Cardiography MonitorsAnalogic Corp. · 2004
- Descendant · cites it directly · 9 of its ownK041294 Biozdx Hemodynamic MonitorCardiodynamics International Corp. · 2004
- Descendant · 2 generations on · 5 of its ownK051228 Biozdx Hemodynamic Monitor and 12-Lead EcgCardiodynamics International Corp. · 2005
- Descendant · 2 generations on · 4 of its ownK060387 Physioflow SystemVasocom, Inc. · 2008
- Descendant · 2 generations on · 4 of its ownK070156 Bioz DX Hemodynamic Monitor with Philips 12-Lead Ecg, Model 5100Cardiodynamics International Corp. · 2007
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K041434C3 and Lifegard Icg Impedance Cardiography MonitorsAnalogic Corp. · 2004 · cites it directly11descendants
- K041294Biozdx Hemodynamic MonitorCardiodynamics International Corp. · 2004 · cites it directly9descendants
- K051228Biozdx Hemodynamic Monitor and 12-Lead EcgCardiodynamics International Corp. · 2005 · 2 generations on5descendants
- K060387Physioflow SystemVasocom, Inc. · 2008 · 2 generations on4descendants
- K070156Bioz DX Hemodynamic Monitor with Philips 12-Lead Ecg, Model 5100Cardiodynamics International Corp. · 2007 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972320 | Bioz System & Bioz Portable | Cardiodynamics International Corp. | 1997 | — |
| 0 (this device) | K974725 | Bioz.Com System | Cardiodynamics International Corp. | 1998 | — |
| +1 | K041434 | C3 and Lifegard Icg Impedance Cardiography Monitors | Analogic Corp. | 2004 | — |
| +1 | K041294 | Biozdx Hemodynamic Monitor | Cardiodynamics International Corp. | 2004 | — |
| +2 | K051228 | Biozdx Hemodynamic Monitor and 12-Lead Ecg | Cardiodynamics International Corp. | 2005 | — |
| +2 | K060387 | Physioflow System | Vasocom, Inc. | 2008 | — |
| +2 | K070156 | Bioz DX Hemodynamic Monitor with Philips 12-Lead Ecg, Model 5100 | Cardiodynamics International Corp. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2023 | 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? (1)
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 |
|---|---|---|---|
| * | K972320 | Bioz System & Bioz PortableSummary page 1…el and manufacturer: Predicate device: CardioDynamics BioZ Portable System Model: BZ - 125 ' Manufacturer: CardioDynamics International, Corp. Predicate device 510(k) # K972320 Reason For Submission: Device Modification -- Repackaging The BioZ.com System is substantially equivalent to its predicate devic… | 1997 |
What descends from it? (19)
See all 193 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?
- Its one ancestor has no recall.
- Of its descendants, K041434 (Analogic Corp., 2004) has gone furthest, with 11 descendants of its own.
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 BioZ.com Hemodynamic Monitor is intended to monitor a
patient’s hemodynamic parameters. These parameters include:
ECG Heart Rate
Pre-ejection Period Left Ventricular Ejection Time
Systolic Time Ratio Stroke Volume
Cardiac Output Cardiac Index
Systemic Vascular Resistance End Diastolic Volume
End Diastolic Index Index of Contractility
Acceleration Index Left Cardiac Work
Thoracic Fluid Content Respiration Rate
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974725 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974725: Bioz.Com System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974725
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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