510(k) Report

FDA applicant

Ohmeda Medical, A Division of Datex-Ohmeda, Inc.

Laurel, MD3 decisions2010–201512 recalls

FDA records 3 decisions for Ohmeda Medical, A Division of Datex-Ohmeda, Inc. (Laurel, MD) from 2010 to 2015: 3 510(k) clearances. Most are in product codes FMT (Warmer, Infant Radiant) and FMZ (Incubator, Neonatal). Its devices cite 5 predicates, 1 of them its own earlier devices. 12 recalls are linked to its devices, 3 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Ohmeda Medical, A Division of Datex-Ohmeda, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2010: 12012: 12015: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

1in 2023

2013: 1, 1 Class I2014: 42018: 52019: 1, 1 Class I2023: 1, 1 Class I
2010high 5 (2018) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Ohmeda Medical, A Division of Datex-Ohmeda, Inc. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FMTWarmer, Infant Radiant2decisions
  • FMZIncubator, Neonatal1decision

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K101804Giraffe and Panda WarmersOhmeda Medical, A Division of Datex-Ohmeda, Inc. · 20102cite it
  • K122267Giraffe and Panda WarmersOhmeda Medical, A Division of Datex-Ohmeda, Inc. · 20122cite it
  • K152809Giraffe Incubator Carestation CS1Ohmeda Medical, A Division of Datex-Ohmeda, Inc. · 20151cites it

What has FDA decided for it lately?

  • K152809Giraffe Incubator Carestation CS1Ohmeda Medical, A Division of Datex-Ohmeda, Inc. · 20152 Class I recalls
  • K122267Giraffe and Panda WarmersOhmeda Medical, A Division of Datex-Ohmeda, Inc. · 20121 Class I recall
  • K101804Giraffe and Panda WarmersOhmeda Medical, A Division of Datex-Ohmeda, Inc. · 20101 Class I recall

All 3 as Ohmeda Medical, A Division of Datex-Ohmeda, Inc. →

What has been recalled?

12 recalls linked to its devices; the latest:

  • K213553GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1)…Jun 6, 2023Class I
  • K152809Giraffe Incubator Carestation, Giraffe Incubator Carestation CS1 infant warmerOct 11, 2019Class I
  • K152809Giraffe Incubator Carestation. Neonatal incubator. Device sold under the following…Sep 25, 2018Class II
  • K070377Panda iRes Infant Radiant Warmer. Device sold under the following product names: Panda…Sep 25, 2018Class II
  • K070377Giraffe Warmer. Device sold under the following product names: Giraffe Warmer and…Sep 25, 2018Class II
  • K070377Panda Freestanding Warmer. Device sold under the following product names: Panda…Sep 25, 2018Class II

Other applicant names beginning “Ohmeda”

FDA records each applicant name separately; these may or may not be the same firm.

Ohmeda Medical 120Ohmeda Anesthesia Systems Therapy Group 2Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE… 1Ohmeda Monitoring Systems 1