# K242931: HFT750U

- Pathway: 510(k) (Traditional)
- Applicant: Mekics Co., Ltd.
- Decided: May 15, 2025 after 232 days
- Product code: MNT (Continuous, Minimal Ventilatory Support, Facility Use Ventilator)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K913368 (1992). 55 ancestors in all.
No later device cites it as a predicate yet.
3 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213521: Nihon Kohden NKV-330 Ventilator System, Nihon Kohden Orangemed, Inc. (2022) Summary page 5.
- K233643: F&P Airvo 3 NIV (PT311US), Fisher & Paykel Healthcare, Ltd. (2024) Summary page 5.

## Indications for use
The HFT750U ventilator is intended to provide ventilation and oxygen concentration for patients who are breathing spontaneously but need partial ventilation support due to respiratory failure or chronic respiratory insufficiency. The device provides heated and humidified gas to the patient. The device is intended for pediatric patients weighing 12.5 kg or greater to adult patients in non-invasive respiratory therapy. Patients with their upper airways bypassed are included. The High Flow mode has a flow range from 1 to 60 lpm. The HFT750U is intended for use in hospitals, hospital-type facilities, and in hospital transportation by qualified and trained users under the directions of a physician. It is not intended for life support.

Source page: https://510kreport.com/device/K242931
Methodology: https://510kreport.com/methodology