BlueDop Vascular Expert

FDA 510(k) K260700 · BlueDop Medical, Ltd.

Substantially Equivalent

510(k) numberK260700

Submission

Device name
BlueDop Vascular Expert
Applicant
BlueDop Medical, Ltd.
London, GB
Received
March 4, 2026
Decision date
July 8, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DPW – Flowmeter, Blood, Cardiovascular
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2100
Specialty
Cardiovascular

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Questions and answers

When was BlueDop Vascular Expert cleared by the FDA?

BlueDop Vascular Expert (K260700) received a 510(k) decision of Substantially Equivalent on July 8, 2026, 126 days after the submission was received.

What is the product code of K260700?

The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.