Cleared Traditional

Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)

K251663 · Datex-Ohmeda, Inc. · General Hospital
Oct 2025
Decision
145d
Days
Class 2
Risk

About This 510(k) Submission

K251663 is an FDA 510(k) clearance for the Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1), a Incubator, Neonatal (Class II — Special Controls, product code FMZ), submitted by Datex-Ohmeda, Inc. (Wauwatosa, US). The FDA issued a Cleared decision on October 22, 2025, 145 days after receiving the submission on May 30, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5400.

Submission Details

510(k) Number K251663 FDA.gov
FDA Decision Cleared SESE
Date Received May 30, 2025
Decision Date October 22, 2025
Days to Decision 145 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMZ — Incubator, Neonatal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5400