BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)
K-Number: K253152 · 2026-05-06
ApplicantBiozen, LLC
Decision Date2026-05-06
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000) is a medical device manufactured by Biozen, LLC. It received FDA 510(k) clearance on 2026-05-06 under approval number K253152. 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 BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)?
BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000) is a medical device that received FDA 510(k) clearance on 2026-05-06. It is manufactured by Biozen, LLC. The 510(k) number is K253152.
When was BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000) approved by the FDA?
BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000) received FDA 510(k) clearance on 2026-05-06, under approval number K253152.
What company makes BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)?
BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000) is manufactured by Biozen, LLC.
What is the FDA product code for BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)?
The FDA product code for BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000) is DXN.
Related Devices (Code: DXN)
K254048Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)Shenzhen Urion Technology Co., Ltd.
K260260Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569)Honsun (Nantong) Co., Ltd.
K252501Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B, DBP-62E1B, DBP-61E3, DBP-61E2, DBP-61E1, DBP-61D7G, DBP-6281L, DBP-6282L, DBP-6285L)Joytech Healthcare Co. , Ltd.
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.