Clearance Summary
mOm Essential Incubator (ME1) received FDA 510(k) clearance under submission number K243437, sponsored by Mom Incubators Limited. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2025-08-14.
- Submission: K243437
- Applicant / Sponsor: Mom Incubators Limited
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5400
- Decision date: 2025-08-14
Classification & Regulation
This clearance is catalogued under FDA product code FMZ and 21 CFR 880.5400, within the General Hospital review panel as a Class II device.