# K200346: Wrist Type Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Avita Corporation
- Decided: Dec 17, 2020 after 310 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: 4 generations back to K042505 (2005). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102624: Avita Wrist Type Blood Pressure Monitor, Avita Corporation (2010) Summary page 4.
- K182166: Wrist Blood Pressure Monitor Model BP4350, Omron Healthcare, Inc. (2018) Summary page 4.

## Indications for use
BPM16B automatically measures human’s Systolic, Diastolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being’s wrist. The intended use of this over-the-counter device is for adults aged 18 years and older with wrist circumference ranging 125 ~ 210 mm (approx. 4.9 ~ 8.3 inch) and for home use

Source page: https://510kreport.com/device/K200346
Methodology: https://510kreport.com/methodology