# K050680: Blood Pressure Monitor with Spectrum/P2, X2, A2, and K7

- Pathway: 510(k) (Traditional)
- Applicant: Ostar Meditech Corp.
- Decided: May 13, 2005 after 58 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: 1 generation back to K012498 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012498: Dynapulse 500G (DP500G) Bllod Pressure Monitoring System, Pulse Metric, Inc. (2001) Summary page 3.

## Indications for use
The Ostar A2, and K7 are indicated for trained medical professionals to operate on patient at clinical settings to collect and measure blood pressure, pulse rate noise index and pressure waveform diagram (including heartbeat waveform and noise waveform). In addition, the Ostar P2 and X2 are indicated for patients at home who are capable and willing to self-administrate this device upon prescription of their healthcare provider P2 and X2 do not display the measuring waveform. The devices do not send any real-time alarms. Clinical judgment and experience are required to check and interpret the information delivered.

Source page: https://510kreport.com/device/K050680
Methodology: https://510kreport.com/methodology