# K231116: Multi-parameter detector

- Pathway: 510(k) (Traditional)
- Applicant: Zhongshan Jinli Electronic Weighing Equipment Co., Ltd.
- Decided: Jun 15, 2024 after 422 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: 14 generations back to K941811 (1994). 146 ancestors in all.
No later device cites it as a predicate yet.
1 of 147 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222979: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W, Microlife Intellectual Property GmbH (2023). Cleared while this submission was under review Summary page 6.
- K210086: Vitals360 Multi-Vitals Mobile Monitor, Vocare, Inc. (2021) Summary page 6.

## Indications for use
The Multi-parameter detector is intended to be used for measuring and displaying of non-invasive blood pressure (NIBP), non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), forehead temperature (TEMP), weight and height in adults. The Multi-parameter detector is also intended to estimate body mass index (BMI), Body fat percentage, visceral fat grade, basal metabolism and free fat mass (muscle mass, bone mass and body water percentage) using the BIA (Bio-electrical Impedance Analysis) method.

Source page: https://510kreport.com/device/K231116
Methodology: https://510kreport.com/methodology