510(k) · Cleared
ClearedBioz.PC Hemodynamic Monitor Model BZ-500/BZ-501; Bioz.PC User Software Installation Kit Model BZ-810
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 30, 2000 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 118 devices in its family, counting itself, has a Class I recall. 117 later devices descend from it.
- Decided
- Jun 30, 2000
- Review
- 87 days
- Class
- Class II
- Product code
- DSB
- Recalls
- None
- Predicates
- 0
117 later devices descend from it, 2 citing it directly. 1 of the 118 devices in this family, counting this one, has a Class I recall.
- This deviceK001081 Bioz.PC Hemodynamic Monitor Model BZ-500/BZ-501; Bioz.PC User…Cardiodynamics International Corp. · 2000
- Descendant · cites it directly · 106 of its ownK014063 Task Force Monitor 3040Cnsystems Medizintechnik GmbH · 2002 · Recalled
- Descendant · 2 generations on · 81 of its ownK023723 Finometer Noninvasive Hemodynamic Monitor, Model 1Fms, Finapres Medical Systems BV · 2003
- Descendant · 3 generations on · 78 of its ownK072049 Continuous Non-Invasive Cardiac Output and Blood Pressure Monitor…Bmeye B.V. · 2007
- Descendant · 4 generations on · 54 of its ownK101123 Nexfin Model 2Bmeye B.V. · 2010
- Descendant · 5 generations on · 53 of its ownK122381 Nexfin Model 2Edwards Lifesciences, LLC · 2013
Showing 5 of 117 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K160552 EV1000 Clinical Platform with ClearSight Finger…7 generations on · 2016
Most influential descendants
Showing 5 of 117 · See all- K014063Task Force Monitor 3040Cnsystems Medizintechnik GmbH · 2002 · cites it directly106descendants
- K023723Finometer Noninvasive Hemodynamic Monitor, Model 1Fms, Finapres Medical Systems BV · 2003 · 2 generations on81descendants
- K072049Continuous Non-Invasive Cardiac Output and Blood Pressure Monitor with Real-Time…Bmeye B.V. · 2007 · 3 generations on78descendants
- K101123Nexfin Model 2Bmeye B.V. · 2010 · 4 generations on54descendants
- K122381Nexfin Model 2Edwards Lifesciences, LLC · 2013 · 5 generations on53descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001081 | Bioz.PC Hemodynamic Monitor Model BZ-500/BZ-501; Bioz.PC User Software… | Cardiodynamics International Corp. | 2000 | — |
| +1 | K014063 | Task Force Monitor 3040 | Cnsystems Medizintechnik GmbH | 2002 | 1 |
| +2 | K023723 | Finometer Noninvasive Hemodynamic Monitor, Model 1 | Fms, Finapres Medical Systems BV | 2003 | — |
| +3 | K072049 | Continuous Non-Invasive Cardiac Output and Blood Pressure Monitor with… | Bmeye B.V. | 2007 | — |
| +4 | K101123 | Nexfin Model 2 | Bmeye B.V. | 2010 | — |
| +5 | K122381 | Nexfin Model 2 | Edwards Lifesciences, LLC | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 8 | 0 |
| 2016 | 2 | 1 |
| 2017 | 4 | 0 |
| 2018 | 8 | 0 |
| 2019 | 11 | 0 |
| 2020 | 1 | 0 |
| 2021 | 8 | 0 |
| 2022 | 9 | 0 |
| 2023 | 14 | 0 |
| 2024 | 7 | 0 |
| 2025 | 14 | 0 |
| 2026 | 8 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (117)
See all 1172 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K160552EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical PlatformEdwards Lifesciences, LLC · 2016 · 7 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K014063 (Cnsystems Medizintechnik GmbH, 2002) has gone furthest, with 106 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 | — |
https://510kreport.com/device/K001081 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001081: Bioz.PC Hemodynamic Monitor Model BZ-500/BZ-501; Bioz.PC User Software Installation Kit Model BZ-810.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001081
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026