Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Biozen, LLC. It received FDA 510(k) clearance on 2026-05-06 under 510(k) 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. The listed applicant is Biozen, LLC. The 510(k) number is K253152.

When did BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000) receive FDA 510(k) clearance?

BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000) received FDA 510(k) clearance on 2026-05-06, under 510(k) number K253152.

Who is the listed applicant for BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)?

The FDA 510(k) record lists Biozen, LLC as the applicant. This does not by itself establish the device manufacturer.

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)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261061BP Go (BPP-855)Wellvii, Inc.K253425Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)Joytech Healthcare Co. , Ltd.K261136Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)Guangzhou Daxin Health Technology Co., Ltd.K261082Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)Microlife CorporationK253126Wrist Blood Pressure Monitor (XW-05)Shenzhen Ziqing Medical Equipment Co., Ltd.K260693VicorderCS (VCS-SYS-1100)80 Beats Medical GmbH

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.

↑