Cleared Traditional

mOm Essential Incubator (ME1)

K243437 · Mom Incubators Limited · General Hospital

Aug 2025

Decision

282d

Days

Class 2

Risk

About This 510(k) Submission

K243437 is an FDA 510(k) clearance for the mOm Essential Incubator (ME1), 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 review panel. Regulated under 21 CFR 880.5400.

Submission Details

510(k) Number	K243437 FDA.gov
FDA Decision	Cleared 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