Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)— 510(k) K260326

Name: FDA 510(k) clearance K260326
Creator: U.S. Food and Drug Administration
Published: 2026-07-28

Substantially Equivalent

Datex-Ohmeda, Inc.

FDA 510(k) clearance K260326 for Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1), Substantially Equivalent on 2026-07-28. Applicant: Datex-Ohmeda, Inc.. Device class: 2.

Clearance details

Applicant: Datex-Ohmeda, Inc.
Product code: Code FMZ
Device class: Class 2
Regulation: 21 CFR 880.5400
Advisory panel: General Hospital
Date received: 2026-01-30
Decision date: 2026-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukesha, WI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FMZ

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K251619 — Babyleo TN5002026-02-13
K251663 — Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)2025-10-22
K243437 — mOm Essential Incubator (ME1)2025-08-14
K213553 — Giraffe Incubator Carestation CS12022-03-02
K190494 — Infant Incubator2019-11-25

More clearances from Datex-Ohmeda, Inc.

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K254036 — Novii+ Wireless Patch System2026-08-10
K213867 — Carestation 750/750c2023-03-28
K213551 — Giraffe Omnibed Carestation CS12022-03-02
K210384 — CARESCAPE R8602021-11-04
K172702 — Tec 820, Tec 8502018-01-04

Adverse events under product code FMZ

product code FMZ

Death: 2
Malfunction: 457
Other: 1
Total: 460

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.