# K242352: Accurate Mini Non-invasive blood pressure monitor (AMB-001)

- Pathway: 510(k) (Traditional)
- Applicant: Accurate Meditech, Inc.
- Decided: Feb 5, 2025 after 181 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 device is a wrist-worn digital monitor intended for use in measuring blood pressure and pulse rate in adult patients of ages 20 -70 with wrist circumference from 13.5 cm to 21.5 cm and BMI<40. The Accurate Mini Non-invasive BPM is intended for spot-checking of adult patients in hospitals, clinics, long-term care, and home use. The measurement results are stored locally in the device. The Accurate Mini 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 Near InfraRed Spectroscopy (NIRS) Optic sensor.

Source page: https://510kreport.com/device/K242352
Methodology: https://510kreport.com/methodology