# K183282: Biovitals Analytics Engine

- Pathway: 510(k) (Traditional)
- Applicant: Biofourmis Singapore Pte., Ltd.
- Decided: Aug 15, 2019 after 262 days
- Product code: PLB (Multivariate Vital Signs Index)
- Device class: 2
- Regulation: 21 CFR 870.2300
- 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 K962603 (1997). 37 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142512: Personalized Physiology Analytics Engine software, Vgbio, Inc (Dba Physiq) (2015) Summary page 4.

## Most influential descendants
- K230386: SpassageQ (2023), 1 descendant of its own
- K240558: Navoycds (2024), 0 descendants of its own

## Indications for use
The Biovitals Analytic Engine (BA Engine) is intended to be used with continuous biometric data from already cleared sensors measuring heart rate, respiratory rate, and activity in ambulatory patients being monitored in a healthcare facility or at home, during periods of minimal activity. The device learns the correlation between multiple vital signs during the patient’s daily activity and builds an individualized biometric signature which is dynamically updated based on incoming data. The device computes a time series Biovitals Index (BI), which reflects changes in the patient’s measured vital signs from their measured baseline, which is derived from the individualized biometric signature of the patient. The BA Engine is a cloud-based software engine, intended to be an adjunct to and is not intended to replace vital signs monitoring. The BI is intended for daily intermittent, retrospective review by a qualified practitioner. The BA Engine is intended to provide additional information for use during routine patient monitoring. The BI is not intended for making clinical decisions regarding patient treatment or for diagnostic purposes. The device is intended for an adult population.

Source page: https://510kreport.com/device/K183282
Methodology: https://510kreport.com/methodology