# K250091: KOROT Blood Pressure Monitor (KOROT P3 Accurate)

- Pathway: 510(k) (Special)
- Applicant: Korot Co., Ltd.
- Decided: Mar 14, 2025 after 59 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 K010828 (2001). 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)
- K221764: InBody Blood pressure monitor, Model BPBIO480KV, Inbody Co., Ltd. (2022) Summary page 5.

## Indications for use
This blood pressure monitor is designed to measure blood pressure (diastolic and systolic) and pulse rate in adult patients with arm circumference range between 22 cm - 52 cm.

Source page: https://510kreport.com/device/K250091
Methodology: https://510kreport.com/methodology