K243437 is an FDA 510(k) clearance for the mOm Essential Incubator (ME1). This device is classified as a Incubator, Neonatal (Class II - Special Controls, product code FMZ).
Submitted by Mom Incubators Limited (Nottingham, GB). The FDA issued a Cleared decision on August 14, 2025, 282 days after receiving the submission on November 5, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5400.
| 510(k) Number | K243437 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 05, 2024 |
| Decision Date | August 14, 2025 |
| Days to Decision | 282 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMZ - Incubator, Neonatal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5400 |