# K222658: Accurate 24 Non-invasive blood pressure monitor

- Pathway: 510(k) (Traditional)
- Applicant: Accurate Meditech, Inc.
- Decided: Jun 21, 2023 after 292 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: 11 generations back to K962603 (1997). 75 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190792: BB-613WP, Biobeat Technologies, Ltd. (2019) Summary page 5.

## Most influential descendants
- K253152: BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000) (2026), 0 descendants of its own
- K242352: Accurate Mini Non-invasive blood pressure monitor (AMB-001) (2025), 0 descendants of its own

## Indications for use
The device is a wrist-worn digital monitor intended for use in measuring blood pressure and pulse rate in adult patient (age 20-70) population with wrist circumference ranging from 13.5 cm to 21.5 cm and BMI<40. The Accurate 24 Non-invasive BPM is intended for spot-checking of adult patients in hospitals, clinics, long-term care, and home use and able to obtain results. The measurement results store in the device locally. The Accurate 24 Non-invasive BPM measures blood pressure based on Pulse Wave Transit Time (PWTT) obtained Local Pulse Wave Velocity (PWV) from dual Piezo Sensors and radial artery parameters from NIRS Optic sensors.

Source page: https://510kreport.com/device/K222658
Methodology: https://510kreport.com/methodology
