Cleared Traditional

HFT750U

K242931 · Mekics Co., Ltd. · Anesthesiology

May 2025

Decision

232d

Days

Class 2

Risk

About This 510(k) Submission

K242931 is an FDA 510(k) clearance for the HFT750U, a Ventilator, Continuous, Minimal Ventilatory Support, Facility Use (Class II — Special Controls, product code MNT), submitted by Mekics Co., Ltd. (Gyeonggi-Do, KR). The FDA issued a Cleared decision on May 15, 2025, 232 days after receiving the submission on September 25, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number	K242931 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 25, 2024
Decision Date	May 15, 2025
Days to Decision	232 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF

Device Classification

Product Code	MNT — Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 868.5895