# K112269: Ostar Usb Blood Pressure Monitor with Spectrum / P200 for Upper Arm, and M100 for Wrist Type

- Pathway: 510(k) (Traditional)
- Applicant: Ostar Meditech Corp.
- Decided: Oct 20, 2011 after 73 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: 6 generations back to K001182 (2000). 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)
- K103046: Hosman Usb Blood Pressure Monitor; Wrist Type and Upper Arm Type, Hosman International Co., Ltd. (2011) Summary page 1.

## Indications for use
OSTAR USB Blood Pressure Monitor Upper Arm Type: P200 and Wrist Type: M100, are noninvasive blood pressure measurement systems intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist or upper rm. The cuff circumference is limited to be 5.5'-7.8'(14 cm -20 cm) for wrist type, and 9'-i 3'(24cm -32cm) for Uipper Arm Type.

Source page: https://510kreport.com/device/K112269
Methodology: https://510kreport.com/methodology