# K140762: Automatic Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Jawon Medical Co., Ltd.
- Decided: Jul 2, 2015 after 462 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: 3 generations back to K895429 (1989). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092432: Automoatic Blood Pressure Monitor, Models: Easy X 800 and 900 (R/L), Jawon Medical Co., Ltd. (2009) Summary page 4.

## Indications for use
The Jawon Upper Arm Automatic Digital Blood Pressure Monitor, Model EX PLUS 1300 is for use by medical professional or home user. The EX PLUS 1300 is a device intended to measure the systolic and diastolic blood pressure, pulse rate and mean blood pressure and inter-arm pressure difference of an adult individual by using a non-invasive oscillometric technique in which one (or two) inflatable cuff(s) is (are) wrapped around the single (or dual) upper arm(s). The cuff size is fit for arm circumference of 23-36 cm. Contraindications for use As with any non-invasive measurement device, there are clinical conditions which can influence the accuracy of the results. Also, the subject’s position, physiological condition and other environmental factors can affect the measurement/calculation. The EX PLUS 1300 Non-Invasive Blood Pressure Monitor should not be used with patients who have the following conditions: 1. Patients with a known arrhythmia. 2. Patients with insufficient peripheral circulation, acute cases of low blood pressure or low temperature. 3. Patients who use a pacemaker. 4. Patients experiencing a seizure. 5. Children younger than 18 years old. 6. Patients who should not have blood pressure measurements taken from their arms. 7. Patients with an artificial heart. 8. Patients whose artery cannot be found by palpation.

Source page: https://510kreport.com/device/K140762
Methodology: https://510kreport.com/methodology