# K230531: SOZO Pro

- Pathway: 510(k) (Special)
- Applicant: ImpediMed Limited
- Decided: May 4, 2023 after 66 days
- Product code: QJB (Adjunct Monitor, Protein Calorie Malnutrition)
- 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: 8 generations back to K922218 (1992). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190529: SOZO, ImpediMed Limited (2019) Summary page 4.

## Indications for use
The SOZO Pro may be used as an adjunct to existing methods by aiding clinicians who are using Subjective Global Assessment (SGA) tools to assess patients at risk of protein-calorie malnutrition (PCM). The SOZO Pro may be further used to estimate the following body composition parameters in humans to track clinically relevant body composition parameters over time: • Fat mass • Fat-free mass • Total body water • Intracellular fluid • Extracellular fluid • Skeletal muscle mass The following outputs are also presented: • Body Mass Index (BMI) • Basal metabolic rate (BMR; based on Mifflin – St. Jeor’s algorithm) displayed in calories per day • Protein and mineral (also known as “dry lean mass”) represents the content of a body that is not fat or fluid; calculated by subtracting total body water weight from fat-free mass weight. The SOZO Pro device measures current (I), voltage (V) and phase angle (Phi), and from these values calculates resistance (R), reactance (Xc), and impedance (Z), which are used to estimate the above body composition parameters. The device/software will also display the Cole plot, subject height, weight, age and sex.

Source page: https://510kreport.com/device/K230531
Methodology: https://510kreport.com/methodology