510(k) K253152
K253152 is an FDA 510(k) premarket notification submitted by Biozen, LLC for the device "BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)". The FDA issued a decision of Substantially Equivalent on May 6, 2026. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 6, 2026
- Date Received
- September 26, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Measurement, Blood-Pressure, Non-Invasive
- Device Class
- Class II
- Regulation Number
- 870.1130
- Review Panel
- CV
- Submission Type