# K230386: SpassageQ

- Pathway: 510(k) (Traditional)
- Applicant: Spass, Inc.
- Decided: Jun 15, 2023 after 121 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: 9 generations back to K962603 (1997). 38 ancestors in all.
1 later device descends 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)
- K183282: Biovitals Analytics Engine, Biofourmis Singapore Pte., Ltd. (2019) Summary page 4.

## Most influential descendants
- K240558: Navoycds (2024), 0 descendants of its own

## Indications for use
The SpassageQ is intended to be used with patient data from already cleared patient monitoring devices which measure respiratory rate, systolic blood pressure, and Glasgow Coma Scale (GCS) in patients being monitored in a healthcare facility. The device provides qSOFA score (also known as quickSOFA) which indicates patients with suspected infection who are at greater risk for a poor outcome. It uses three criteria, assigning one point for low blood pressure (SBP≤100 mmHg), high respiratory rate (≥22 breaths per min), or altered mentation (Glasgow coma scale<15). The SpassageQ is an adjunct to and is not intended to replace vital signs monitoring. The device is intended to provide additional information for use during patient monitoring in a healthcare facility. The device 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/K230386
Methodology: https://510kreport.com/methodology