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510(k) K243437

mOm Essential Incubator (ME1) by Mom Incubators Limited — Product Code FMZ

K243437 is an FDA 510(k) premarket notification submitted by Mom Incubators Limited for the device "mOm Essential Incubator (ME1)". The FDA issued a decision of Substantially Equivalent on August 14, 2025. The device falls under product code FMZ (Incubator, Neonatal), a Class II device regulated under 21 CFR 880.5400.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2025
Date Received
November 5, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Incubator, Neonatal
Device Class
Class II
Regulation Number
880.5400
Review Panel
HO
Submission Type

Other clearances for product code FMZ

  • K251619 — Babyleo TN500 (February 13, 2026)
  • K251663 — Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) (October 22, 2025)
  • K213553 — Giraffe Incubator Carestation CS1 (March 2, 2022)
  • K190494 — Infant Incubator (November 25, 2019)
  • K182859 — Babyleo TN500 (February 22, 2019)
  • K182977 — Isolette 8000 Plus (November 21, 2018)
  • K172154 — Isolette 8000 plus (April 19, 2018)
  • K162821 — Babyleo TN500 (June 23, 2017)
  • K152814 — Giraffe OmniBed Carestation CS1 (March 17, 2016)
  • K152809 — Giraffe Incubator Carestation CS1 (December 31, 2015)

FDA data resources