# K040909: Sono TT Ultrasonic Flowcomputer

- Pathway: 510(k) (Traditional)
- Applicant: Em-Tec GmbH
- Decided: Apr 20, 2004 after 12 days
- Product code: DPW (Flowmeter, Blood, Cardiovascular)
- Device class: 2
- Regulation: 21 CFR 870.2100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Sono TT Ultrasonic Flowcomputer in combination with an ultrasonic clamp-on Transducer is indicated for the contact less volumetric measurement of liquid flowing through tubing systems. The measurement principle is the ultrasound transit-time method. The medical use of the device is appropriate in the following extracorporeal procedures: - Cardio-pulmonary bypass, membrane-oxygenation, hemodialysis, hemofiltration, plasmapheresis - Perfusion, infusion, transfusion - Several shunt-applications The Flowcomputer can be used in intensive care units and operating rooms. For the patient's safety the device is to be operated only by qualified medically-trained personnel. Contraindication: This device has been built and sold only for the intended purpose mentioned above. The supplied measured values serve only to monitor the flow rate of the device in use (e.g. oxygenator, blood pump). These values are not to be used either for an evaluation of a patient's status or for the basis of medical actions without the confirmation of another approved medical measurement procedure. It is the operator's responsibility to use the device as described in the User's Manual and in any of its following revision releases. The use of clinical procedures and techniques lie in the physician's area of responsibility.

Source page: https://510kreport.com/device/K040909
Methodology: https://510kreport.com/methodology