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FDA 510(k)

BP Go (BPP-855)

K-Number: K261061 · 2026-08-13

ApplicantWellvii, Inc.
Decision Date2026-08-13
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BP Go (BPP-855) is the device name listed in this FDA 510(k) record. The listed applicant is Wellvii, Inc.. It received FDA 510(k) clearance on 2026-08-13 under 510(k) number K261061. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BP Go (BPP-855)?

BP Go (BPP-855) is a medical device that received FDA 510(k) clearance on 2026-08-13. The listed applicant is Wellvii, Inc.. The 510(k) number is K261061.

When did BP Go (BPP-855) receive FDA 510(k) clearance?

BP Go (BPP-855) received FDA 510(k) clearance on 2026-08-13, under 510(k) number K261061.

Who is the listed applicant for BP Go (BPP-855)?

The FDA 510(k) record lists Wellvii, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BP Go (BPP-855)?

The FDA product code for BP Go (BPP-855) is DXN.

Other records listing Wellvii, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: DXN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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