K242931 is an FDA 510(k) clearance for the HFT750U. This device is classified as 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 FDA review panel. Regulated under 21 CFR 868.5895.
| 510(k) Number | K242931 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | MNT - Ventilator, Continuous, Minimal Ventilatory Support, Facility Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5895 |