# K102033: Combitrans Monitoring Sets and Accessories

- Pathway: 510(k) (Abbreviated)
- Applicant: B.Braun Melsungen AG
- Decided: Apr 7, 2011 after 262 days
- Product code: DRS (Transducer, Blood-Pressure, Extravascular)
- Device class: 2
- Regulation: 21 CFR 870.2850
- 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 K841788 (1985). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070710: Accutrans Disposable Pressure Monitoring System, Biosensors International-USA (2007) Summary page 1.

## Indications for use
The B. Braun Combitrans Monitoring Set is. intended for the extravascular measurement of venous, arterial, or pulmonary arterial blood pressure by converting hemodynamic waveforms into electrical signals. The Combitrans flush device provides a continuous flush rate from approximately 3 mllhr and allows a switch to approximately 300 mI/hr. When using the Combitrans device in neonates, infants or small children a syringe pump should be used to control the flow rate, as the flow rate should not exceed 3 nmI/h.-

Source page: https://510kreport.com/device/K102033
Methodology: https://510kreport.com/methodology