# K001081: Bioz.PC Hemodynamic Monitor Model BZ-500/BZ-501; Bioz.PC User Software Installation Kit Model BZ-810

- Pathway: 510(k) (Traditional)
- Applicant: Cardiodynamics International Corp.
- Decided: Jun 30, 2000 after 87 days
- Product code: DSB (Plethysmograph, Impedance)
- Device class: 2
- Regulation: 21 CFR 870.2770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
117 later devices descend from it; 2 cite it directly.
1 of 118 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K014063: Task Force Monitor 3040 (2002), 106 descendants of its own
- K023723: Finometer Noninvasive Hemodynamic Monitor, Model 1 (2003), 81 descendants of its own
- K072049: Continuous Non-Invasive Cardiac Output and Blood Pressure Monitor with Real-Time Hemodynamics (2007), 78 descendants of its own
- K101123: Nexfin Model 2 (2010), 54 descendants of its own
- K122381: Nexfin Model 2 (2013), 53 descendants of its own

Source page: https://510kreport.com/device/K001081
Methodology: https://510kreport.com/methodology