Cleared Traditional

K240756 - AITRICS-VC

K240756 is an FDA 510(k) clearance for AITRICS-VC, manufactured by Aitrics Co., Ltd.. The device is a Class 2 Cardiovascular device with product code PLB cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K240756 · Aitrics Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2024
Decision
125d
Days
Class 2
Risk

K240756 is an FDA 510(k) clearance for the AITRICS-VC. Classified as Multivariate Vital Signs Index (product code PLB), Class II - Special Controls.

Submitted by Aitrics Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on July 23, 2024 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Aitrics Co., Ltd. devices

FDA 510(k) Submission Details - K240756

510(k) Number K240756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2024
Decision Date July 23, 2024
Days to Decision 125 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 125d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PLB Device Classification - Class 2, Special Controls

Product Code PLB Multivariate Vital Signs Index
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
Definition Automated Calculation Of A Summary Index (or Indices) Based On Several Individual Measured Vital Sign Inputs.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.