# K963183: Bioz System

- Pathway: 510(k) (Traditional)
- Applicant: Cardiodynamics International Corp.
- Decided: Nov 26, 1996 after 104 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.
13 later devices descend from it; 1 cites it directly.
1 of 14 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K021174: Ecom Endotrachial Cardiac Output Monitor (2003), 12 descendants of its own
- K032491: Ecom CV4 Endotracheal Cardiac Output Monitor (2003), 11 descendants of its own
- K094054: Modifcation to: Nuvasive Neurovision Emg Endotracheal Tube (2010), 8 descendants of its own
- K110989: Neurovision Ink Printed Endotracheal Tube Electrode (2011), 4 descendants of its own
- K221821: ATEC IOM Accessory Instruments (2022), 1 descendant of its own

Source page: https://510kreport.com/device/K963183
Methodology: https://510kreport.com/methodology