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510(k) K251663

Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) by Datex-Ohmeda, Inc. — Product Code FMZ

K251663 is an FDA 510(k) premarket notification submitted by Datex-Ohmeda, Inc. for the device "Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)". The FDA issued a decision of Substantially Equivalent on October 22, 2025. The device falls under product code FMZ (Incubator, Neonatal), a Class II device regulated under 21 CFR 880.5400. Datex-Ohmeda, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 2025
Date Received
May 30, 2025
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 by Datex-Ohmeda, Inc.

  • K213867 — Carestation 750/750c (March 28, 2023)
  • K210384 — CARESCAPE R860 (November 4, 2021)
  • K172702 — Tec 820, Tec 850 (January 4, 2018)
  • K172045 — Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aesp (November 3, 2017)
  • K170872 — Aisys CS2 (August 15, 2017)
  • K151570 — Carestation 620/650/650C (January 21, 2016)
  • K142679 — CARESCAPE R860 (June 12, 2015)
  • K143530 — Aespire View (April 24, 2015)
  • K140575 — ENGSTROM CARESTATION, ENGSTROM PRO (February 3, 2015)
  • K132530 — GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2) (December 20, 2013)

Other clearances for product code FMZ

  • K251619 — Babyleo TN500 (February 13, 2026)
  • K243437 — mOm Essential Incubator (ME1) (August 14, 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