BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)

BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000) is an FDA 510(k)-cleared medical device (K253152) manufactured by Biozen, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 5, 2026. Regulation: 8.