# K022963: Transonic Syringe Warmer, Model Syr-1000

- Pathway: 510(k) (Traditional)
- Applicant: Transonic Systems, Inc.
- Decided: Dec 4, 2002 after 89 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: 2 generations back to K960817 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980906: Transonic Hemodialysis Monitor, Cardiac Output, Model HD01-CO, Transonic Systems, Inc. (1998) Summary page 1.
- (no number) Vista Dental Syringe Warmer: named in the summary without a submission number

## Indications for use
The Transonic Syringe Warmer (Model SYR1000) is indicated for use with the Transonic HD0l (HDO1p'usand HD02) systems to make Cardiac output measurements. The Transonic Syringe Warmer (Model SYR1000) is an accessory to our HDOl-CO Hemodialysis Monitor for Cardiac Output (K980906) which are currently marketed as the HDO1p'usand HD02 systems. The HDO1-CO Hemodialysis Monitor for Cardiac Output (HDOlp'usand HD02 systems) requires the user to make a 30cc injection of approximately body temperature saline into the hemodialysis blood circuit for the CO measurement. The syringe warmer provides the user a convenient source of the 30cc injection of approximately body temperature saline for this injection.

Source page: https://510kreport.com/device/K022963
Methodology: https://510kreport.com/methodology