510(k) · Cleared
ClearedBioz System & Bioz Portable
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 Sep 11, 1997 after an 80-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 20 later devices descend from it.
- Decided
- Sep 11, 1997
- Review
- 80 days
- Class
- Class II
- Product code
- DSB
- Recalls
- None
- Predicates
- 0
20 later devices descend from it, 1 citing it directly.
- This deviceK972320 Bioz System & Bioz PortableCardiodynamics International Corp. · 1997
- Descendant · cites it directly · 19 of its ownK974725 Bioz.Com SystemCardiodynamics International Corp. · 1998
- Descendant · 2 generations on · 11 of its ownK041434 C3 and Lifegard Icg Impedance Cardiography MonitorsAnalogic Corp. · 2004
- Descendant · 2 generations on · 9 of its ownK041294 Biozdx Hemodynamic MonitorCardiodynamics International Corp. · 2004
- Descendant · 3 generations on · 5 of its ownK051228 Biozdx Hemodynamic Monitor and 12-Lead EcgCardiodynamics International Corp. · 2005
- Descendant · 3 generations on · 4 of its ownK060387 Physioflow SystemVasocom, Inc. · 2008
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K974725Bioz.Com SystemCardiodynamics International Corp. · 1998 · cites it directly19descendants
- K041434C3 and Lifegard Icg Impedance Cardiography MonitorsAnalogic Corp. · 2004 · 2 generations on11descendants
- K041294Biozdx Hemodynamic MonitorCardiodynamics International Corp. · 2004 · 2 generations on9descendants
- K051228Biozdx Hemodynamic Monitor and 12-Lead EcgCardiodynamics International Corp. · 2005 · 3 generations on5descendants
- K060387Physioflow SystemVasocom, Inc. · 2008 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972320 | Bioz System & Bioz Portable | Cardiodynamics International Corp. | 1997 | — |
| +1 | K974725 | Bioz.Com System | Cardiodynamics International Corp. | 1998 | — |
| +2 | K041434 | C3 and Lifegard Icg Impedance Cardiography Monitors | Analogic Corp. | 2004 | — |
| +2 | K041294 | Biozdx Hemodynamic Monitor | Cardiodynamics International Corp. | 2004 | — |
| +3 | K051228 | Biozdx Hemodynamic Monitor and 12-Lead Ecg | Cardiodynamics International Corp. | 2005 | — |
| +3 | K060387 | Physioflow System | Vasocom, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 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 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (20)
See all 201 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K974725 | Bioz.Com System | 1998 | 19 |
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?
- Of its descendants, K974725 (Cardiodynamics International Corp., 1998) has gone furthest, with 19 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 System was designed to monitor a patients hemodynamic parameters. These include ECG, HR, PEP, LVET, STR, SV, S1, CO, CI, SVR. SVRI, EDV, EDI, IC, ACI, LCW and TFC.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972320 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972320: Bioz System & Bioz Portable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972320
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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