# K133903: Bio-Probe Transducer (Adult)

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Apr 10, 2014 after 111 days
- Product code: DPT (Probe, Blood-Flow, Extravascular)
- Device class: 2
- Regulation: 21 CFR 870.2120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K915183 (1992). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070286: Bio-Console, Model 560, Medtronic (2007) Summary page 1.

## Indications for use
The Bio-Probe blood flow monitoring system is to be used with an appropriate model Bio-Consoie extracorporeal blood pumping console to measure directly the blood flow in the extracorporeal perfusion circuit.

Source page: https://510kreport.com/device/K133903
Methodology: https://510kreport.com/methodology