# K200560: InBody

- Pathway: 510(k) (Abbreviated)
- Applicant: Inbody Co., Ltd.
- Decided: Jan 6, 2021 after 308 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 K871718 (1987). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061456: A & D Medical UM-101 Digital Blood Pressure Monitor, A&D Engineering, Inc. (2006) Summary page 4.

## Indications for use
The subject device is a manual blood pressure (BP) monitor, and requires the user to listen for Korotkoff sounds to determine systolic and diastolic pressure. Further, patients whose Korotkoff sounds are not clear or absent, such as children younger than 3 years of age, will not be suitable for the subject device. Pulse rate is also measured.

Source page: https://510kreport.com/device/K200560
Methodology: https://510kreport.com/methodology