# K200442: InBody

- Pathway: 510(k) (Abbreviated)
- Applicant: Inbody Co., Ltd.
- Decided: Dec 4, 2020 after 284 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: 2 generations back to K010828 (2001). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131064: Biospace, Biospace Corporation Limited (2013) Summary page 4.

## Most influential descendants
- K221764: InBody Blood pressure monitor, Model BPBIO480KV (2022), 1 descendant of its own
- K250091: KOROT Blood Pressure Monitor (KOROT P3 Accurate) (2025), 0 descendants of its own

## Indications for use
The Inbody blood pressure monitor is designed to measure blood pressure (diastolic and systolic) and pulse rate in adult patients with arm circumference range between 17cm - 42cm. The models of BP170, BP170B, BP160 and BP160B are designated as both Prescription use and Over-the-counter use. The model of BPBIO250 is designated as Prescription use only.

Source page: https://510kreport.com/device/K200442
Methodology: https://510kreport.com/methodology