# K980906: Transonic Hemodialysis Monitor, Cardiac Output, Model HD01-CO

- Pathway: 510(k) (Traditional)
- Applicant: Transonic Systems, Inc.
- Decided: Oct 6, 1998 after 210 days
- Product code: MQS (System, Hemodialysis, Access Recirculation Monitoring)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K960817 (1997). 1 ancestor in all.
10 later devices descend from it; 4 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960817: HD01-Series Transonic Hemodialysis Monitor (R%,QA,CO,QB,QB2), Transonic Systems, Inc. (1997). Our OCR of the scanned summary read “K960817” beside “510(k)”; FDA’s K960817 is the only number that fits it and carries the summary’s name for the device. Summary page 5.

## Most influential descendants
- K030456: Vasc-Alert (2003), 5 descendants of its own
- K042566: Vasc-Alert (2004), 4 descendants of its own
- K093834: Crit-Line Anemia Management Software (2010), 3 descendants of its own
- K130579: Physoft Ams (2013), 2 descendants of its own
- K080116: Transonic Costatus Cardiac Output System (2008), 2 descendants of its own

## Indications for use
The HDO1-CO monitor is intended for use by trained medical personnel, for assessment of a patient’s hemodynamic condition through estimation of cardiac output while undergoing hemodialysis treatment in a non-critical care setting. For use only by or on the order of a physician licensed by law to use or order the use of this device.

Source page: https://510kreport.com/device/K980906
Methodology: https://510kreport.com/methodology