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AITRICS-VC

by Aitrics Co., Ltd.

510(k) K240756

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK240756 Date23 Jul 2024ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
PLB
Device Class
Class II
Regulation
21 CFR Part 870.2300
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

AITRICS-VC is a multivariate vital signs index software device classified under product code PLB and regulation number 870.2300. It is substantially equivalent to a predicate device and received traditional FDA 510(k) clearance (K240756) on July 23, 2024. The device is intended for use in cardiovascular-related medical specialties as indicated by its classification and advisory committee review.

AITRICS-VC uses electronic medical record (EMR) data from hospitalized patients aged 19 and older to predict the risk of major adverse events (including mortality, unexpected ICU transfer, and CPR), sepsis, and acute deterioration (including mortality) in both general wards and the ICU. It is supplied as software and operates based on the specifications and authorisations documented in its FDA 510(k) submission. No information regarding sterility, single-use or reusable status, MRI safety, physical sizes, or storage conditions is provided in the device data.

Questions

AI-generated answers, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is AITRICS-VC used for?

    AITRICS-VC is intended for use in cardiovascular-related medical specialties to predict the risk of major adverse events (including mortality, unexpected ICU transfer, and CPR), sepsis, and acute deterioration (including mortality) in hospitalized patients aged 19 and older, using electronic medical record data from both general wards and the ICU.

  • How is AITRICS-VC supplied and what type of device is it?

    AITRICS-VC is supplied as software and operates as a multivariate vital signs index device, based on the specifications and authorizations documented in its FDA 510(k) submission (K240756), with no physical components, sterility, or reusable/single-use status applicable.

  • What regulatory pathway was used for AITRICS-VC and when was it cleared?

    AITRICS-VC received traditional FDA 510(k) clearance (K240756) on July 23, 2024, as a substantially equivalent device to a predicate, classified under product code PLB and regulation number 870.2300, following review by the Cardiovascular advisory committee.