FDA 510(k) · Aitrics
K240756: AITRICS-VC (Aitrics Co., Ltd.)
Aitrics Co., Ltd. received FDA 510(k) K240756 for AITRICS-VC, with a decision date of Jul 23, 2024 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K240756 |
|---|---|
| Pathway | 510(k) |
| Applicant | Aitrics Co., Ltd. |
| Device name | AITRICS-VC |
| Product code | PLB: Multivariate Vital Signs Index |
| Regulation (21 CFR) | 870.2300 |
| Device class | Class 2 |
| Date received | Mar 20, 2024 |
| Decision date | Jul 23, 2024 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
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.
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code PLB is "Multivariate Vital Signs Index", class 2, 21 CFR 870.2300. FDA's definition: "Automated calculation of a summary index (or indices) based on several individual measured vital sign inputs."
Our labels for filtering: claim Remote / vital-sign monitoring, sensor Unknown. These are heuristics, not FDA fields.