# K253133: Wrist Blood Pressure Monitor (BPM-W1VL)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Imdk Medical Technology Co., Ltd.
- Decided: Feb 13, 2026 after 141 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: 4 generations back to K042505 (2005). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231310: Electronic Blood Pressure Monitor, Shenzhen Jumper Medical Equipment Co., Ltd. (2023) Summary page 6.

## Indications for use
The Wrist Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of person older than twelve (12) years via non-invasive oscillometric technique in medical facilities or at home. The intended wrist circumference is 13.5-21.5 cm. Contraindications: 1). Patients with severe heart (including significantly irregular heart rhythm, Bigeminy, trigeminy, isolated ventricular premature beat (VPB), atrial fibrillation), liver or kidney disease or blood circulation disorders. 2). Newborns, infants, children, people with mental disorders and people who cannot explain their thoughts; 3). The one who with upper limb trauma don't use this device; 4). The one who with artificial heart and skin ulcers is prohibited to use this device. 5). Patients are Pregnant; 6). Patients has been diagnosed with preeclampsia. 7). Patients with diabetes. 8). Patients who are undergoing vasoactive treatment. 9). Patients with (such as atrial fibrillation). 10). Patients with peripheral artery disease or other conditions that affect arterial compliance.

Source page: https://510kreport.com/device/K253133
Methodology: https://510kreport.com/methodology