BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)— 510(k) K253152
Substantially EquivalentBiozen, LLC
FDA 510(k) clearance K253152 for BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000), Substantially Equivalent on 2026-05-06. Applicant: Biozen, LLC. Device class: 2.
Summary
Biozen's BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000) is filed under DXN, non-invasive blood pressure measurement systems.
Class II, 21 CFR 870.1130. Cardiovascular is both the classification panel and the review panel, and the submission was a Traditional 510(k).
Biozen filed from Oklahoma City, Oklahoma. The decision came 222 calendar days after receipt (September 26, 2025 to May 6, 2026).
Clearance details
- Applicant
- Biozen, LLC
- 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
- Oklahoma City, OK, US
Recent devices under product code DXN
view all- K260670 — YUWELL® Electronic Blood Pressure Monitor
- 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)
Adverse 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.