510(k) Report

FDA applicant

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

Laurel, MD1 decision2016–20168 recalls

FDA records 1 decision for Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company (Laurel, MD) in 2016: 1 510(k) clearance. All are in product code FMZ (Incubator, Neonatal). Its devices cite 4 predicates, 0 of them its own earlier devices. 8 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. A GE Company’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2016: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

2in 2026

2018: 12019: 2, 1 Class I2023: 2, 1 Class I2024: 1, 1 Class I2026 (partial year): 2
2016high 2 (2019) · low 0 (2016)2026

Class I Class II/III not classified

FIG. 1 — Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ohmeda Medical, A Division of…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • FMZIncubator, Neonatal1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K152814Giraffe OmniBed Carestation CS1Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company · 20161cites it

What has FDA decided for it lately?

  • K152814Giraffe OmniBed Carestation CS1Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company · 20163 Class I recalls

The one decision as Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company →

What has been recalled?

8 recalls linked to its devices; the latest:

  • K020543Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and…May 1, 2026Class II
  • K152814Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combination of an…May 1, 2026Class II
  • K213551GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal…Sep 3, 2024Class I
  • K213551GE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator and infant…Jun 6, 2023Class I
  • K152814Giraffe OmniBed Carestation CS1, Model Numbers: a. 2082844-001-XXX, b.…May 19, 2023Class II
  • K152814Giraffe OmniBed Carestation, Model Numbers: 2082844-001-XXXXXX; Giraffe OmniBed…Oct 11, 2019Class I

Other applicant names beginning “Ohmeda”

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

Ohmeda Medical 120Ohmeda Medical, A Division of Datex-Ohmeda, Inc. 3Ohmeda Anesthesia Systems Therapy Group 2Ohmeda Monitoring Systems 1