# K240756: Aitrics-VC

- Pathway: 510(k) (Traditional)
- Applicant: Aitrics Co., Ltd.
- Decided: Jul 23, 2024 after 125 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: 30 generations back to K941811 (1994). 178 ancestors in all.
No later device cites it as a predicate yet.
0 of 179 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213335: Capsule Surveillance System, Capsule Surveillance Technologies, Sas /Capsule Tech, Inc. (2022) Summary page 5.

## Indications for use
The AITRICS-VC is stand-alone software intended to analyze patient data sourced from an EHR (Electronic Health Record) system and display data of in-hospital patients. It displays patient data whose vital signs, blood test results, or conventional early warning scores such as MEWS, NEWS, and qSOFA exceed predefined thresholds. It is not intended to replace bedside patient monitors or clinicians' clinical decision-making. It is not indicated for use in high-acuity environments like the ICU or operating rooms for acutely or critically ill patients. It may be used by clinicians to aid in understanding a patient's current condition and changes over time. The AITRICS-VC is solely indicated for use in the general ward of a hospital environment.

Source page: https://510kreport.com/device/K240756
Methodology: https://510kreport.com/methodology