BP Go (BPP-855)— 510(k) K261061
Substantially EquivalentWellvii, Inc.
FDA 510(k) clearance K261061 for BP Go (BPP-855), Substantially Equivalent on 2026-08-13. Applicant: Wellvii, Inc.. Device class: 2.
Summary
Wellvii's BP Go, model BPP-855, is filed under product code DXN, non-invasive blood-pressure measurement systems. No other models are listed.
Class II, 21 CFR 870.1130. Cardiovascular is both the classification panel and the review panel, and the submission type is Traditional.
Wellvii filed from Palm Beach Gardens, Florida. FDA found it substantially equivalent 135 calendar days after receipt (March 31 to August 13, 2026).
Clearance details
- Applicant
- Wellvii, Inc.
- Product code
- Product code DXN
- Device class
- Class 2
- Regulation
- 21 CFR 870.1130
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Palm Beach Gardens, FL, US
Recent devices under product code DXN
view all- K260470 — Electronic Blood Pressure Monitor (BP-204C, BP-204A, BP-215, BP-203C, BP-205A, BP-201C, BP-217, BP-202C, BP-202 BP-205, BP-205B,BP-206)
- K261929 — Upper Arm Blood pressure monitor (BP7155D)
- K254000 — Happy Health Blood Pressure Monitor
- K262658 — Automatic Digital Blood Pressure monitor (LD-526)
- K261394 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus)
More clearances from Wellvii, Inc.
view allAdverse events under product code DXN
product code DXN- Death
- 3
- Injury
- 169
- Malfunction
- 1,019
- Other
- 2
- Total
- 1,193
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.