# K260700: BlueDop Vascular Expert

- Pathway: 510(k) (Traditional)
- Applicant: BlueDop Medical, Ltd.
- Decided: Jul 8, 2026 after 126 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
Longest line of descent: 2 generations back to K082870 (2008). 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)
- K212065: VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger, Remington Medical, Inc. (2021) Summary page 5.

## Indications for use
The BlueDop Vascular Expert (BVE) is intended to non-invasively detect the presence of blood flow in peripheral arteries using Doppler ultrasound technology. The device provides Doppler waveform information to support clinical evaluation of peripheral vascular status. The BVE is intended to be used as an adjunct to standard clinical assessment and does not provide a standalone diagnostic determination.

Source page: https://510kreport.com/device/K260700
Methodology: https://510kreport.com/methodology