Class Class II
mOm Essential Incubator (ME1) (K243437)
Description
mOm Essential Incubator (ME1) by Mom Incubators Limited, an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243437
Clearance Date2025-08-14
Clearance TypeTraditional
Product CodeFMZ
Regulation Number880.5400
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243437
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. mOm Essential Incubator (ME1) (K243437) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K172154 | Isolette 8000 plus | Draeger Medical Sytems, Inc. | 2018 |
Trace the full predicate network for K243437
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.