# K051565: Proton Digital Blood Pressure Monitor, Models PH168A, PH168E, PH168W, PHC888JA, PH888HA

- Pathway: 510(k) (Traditional)
- Applicant: Proton Healthcare, Ltd.
- Decided: Sep 12, 2005 after 90 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
All five models automatically measures human's Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD Panel. The intended use of Models PH168A, PH168E and PH168W is for age 16 and above. The intended use for the Models PHC888JA and PH888HA is for adult patients whose arm circumference is between 24-32cm (approx. 8.7" to 12.6").

Source page: https://510kreport.com/device/K051565
Methodology: https://510kreport.com/methodology