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HFT750U

by MEKICS Co., Ltd

510(k) K242931

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK242931 Date15 May 2025ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
MNT
FDA applicant
Mekics Co., Ltd.
Device Class
Class II
Regulation
21 CFR Part 868.5895
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

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

The HFT750U is a Sv70 Ventilator, classified as a Class II medical device under product code MNT and regulation number 868.5895. It is substantially equivalent to a predicate device and has been reviewed by the Anesthesiology advisory committee.

The device received FDA 510(k) clearance (K242931) on May 15, 2025, following a traditional review process. It is manufactured by MEKICS Co., Ltd. and is intended for use in anesthesiology settings as indicated by the advisory committee classification.

Other devices from MEKICS Co., Ltd

See all devices from MEKICS Co., Ltd →

Questions

AI-generated answers, 26 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 the HFT750U Sv70 Ventilator intended for?

    The HFT750U is intended for use in anesthesiology settings, as indicated by its classification under the Anesthesiology advisory committee and product code MNT, which corresponds to ventilators used in anesthesia delivery systems.

  • How was the HFT750U cleared for market release?

    The HFT750U received FDA 510(k) clearance through a traditional review process, with clearance granted on May 15, 2025, under K242931, based on substantial equivalence to a predicate device.

  • What regulatory classification does the HFT750U hold?

    The HFT750U is classified as a Class II medical device under FDA regulation number 868.5895 and product code MNT, reflecting its risk level and intended use in anesthesiology.

  • Who manufactures the HFT750U Sv70 Ventilator?

    The HFT750U is manufactured by MEKICS Co., Ltd., a company based in Gyeonggi-Do, South Korea, as specified in the device’s registration and applicant information.