# K221486: Index BPM

- Pathway: 510(k) (Traditional)
- Applicant: Ya Horng Electronic Co., Ltd.
- Decided: Aug 30, 2022 after 99 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
The INDEX ™ BPM device is a tubeless blood pressure monitor. This is a medical device intended to measure systolic and diastolic blood pressure and pulse rate. The device is designed for adults age 18 to 75 with an upper arm circumference of 22 to 42 cm (8.6 to 16.5 in).

Source page: https://510kreport.com/device/K221486
Methodology: https://510kreport.com/methodology