# K111730: Sonott Flowlab (R)

- Pathway: 510(k) (Abbreviated)
- Applicant: Em-Tec GmbH
- Decided: Jan 6, 2012 after 200 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. The FDA summary names its predicate without a number.
- (no number) MediStim VeriQ VQ1 001- VQ4122: named in the summary without a submission number
- (no number) SonoTT Ultrasonic Flowcomputer: named in the summary without a submission number

## Indications for use
The SonoTT FlowLab® with the accessories is a system to measure the flow rate of liquids (e.g. blood) with the ultrasonic transit-time and velocity patterns of blood with Doppler method. It supports the planning, implementation, efficiency control and documentation of interventions carried out in the area of cardiovascular, vascular and, transplantation, or the monitoring of extracorporeal circulatory systems. The following medical applications are supported: * Intraoperative blood flow measurement with the SonoTT Vascular Probe to assist surgeons at surgical interventions * Measurement of flow direction and velocities of blood in vessels using the SonoTT Pulse Wave Doppler Probe to assist the surgeon in the non-invasive assessment of vascular changes. * Extracorporeal flow measurement in continuous operation on tube systems in combination with the SonoTT Clamp-On Transducer in intensive care units and operating theatres The following actions can be performed simultaneously when these measurements are in progress: * Pressure measurement in combination with a standard blood pressure transducer * Secondary displays of additional physiological analogue signals and corresponding derived parameters The SonoTT Vascular Probe is intended for transient use only with continuous contact with patient of less than 60 minutes. For the patient's safety they must be operated by qualified medical personnel.

Source page: https://510kreport.com/device/K111730
Methodology: https://510kreport.com/methodology