# K122388: Seca Medical Body Compostion Analyzer 514, Seca Mbca 514, Seca Mbca, Seca 514

- Pathway: 510(k) (Traditional)
- Applicant: Seca GmbH & Co. KG
- Decided: May 2, 2013 after 269 days
- Product code: MNW (Analyzer, Body Composition)
- Device class: 2
- Regulation: 21 CFR 870.2770
- 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 K830292 (1983). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052646: Biospace Body Composition Analyzers, Models Inbody 520, 720 and S20, Biospace Corporation Limited (2005) Summary page 1.

## Indications for use
The seca mECA 514 measures body Weight and records body Height for calculation of Body Mass Index (BMI), Resting Energy Expenditure (REE) and Total Energy Expenditure (TEE) to monitor growth process and weight changes in individuals of all ages. In healthy individuals aged 18 years and older the device also measures body impedance (Reactance Xc and Resistance R) for estimation of body composition. Estimation of body composition includes Total Body Water (TBW), Intra Cellular Water (ICW), Extra Cellular Water (ECW), Lean Soft Tissue (LST), Fat-Free Mass (PPM), Fat Mass (FM), Fat Mass Indices (EMI and FMI), Skeletal Muscle Mass (SMM), Bioelectrical Impedance Vector Analysis (BIVA), Energy stored in body (Ewy) and Phase Angle (0). The seca mBCA 514 can be used in conjunction with the optional PC software accessory seca analytics 115 for data management, calculations and display of information.

Source page: https://510kreport.com/device/K122388
Methodology: https://510kreport.com/methodology