# K253152: BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)

- Pathway: 510(k) (Traditional)
- Applicant: Biozen, LLC
- Decided: May 6, 2026 after 222 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K962603 (1997). 76 ancestors in all.
No later device cites it as a predicate yet.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222658: Accurate 24 Non-invasive blood pressure monitor, Accurate Meditech, Inc. (2023) Summary page 5.

## Indications for use
The Biozen BP1000 Ultra-Compact Fingertip Blood Pressure monitor is a digital monitor intended for use in spot check measurements of blood pressure in the adult population using photoplethysmogram and pressure signals obtained from the index finger. User Population: Adults ages 22-59 who do not have active arrythmias (e.g. Afib), peripheral artery disease, or are pregnant. Environment of Use: Home

Source page: https://510kreport.com/device/K253152
Methodology: https://510kreport.com/methodology