Cleared Special

K152814 - Giraffe OmniBed Carestation CS1 (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K152814 · Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company · General Hospital
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Mar 2016
Decision
171d
Days
Class 2
Risk

K152814 is an FDA 510(k) clearance for the Giraffe OmniBed Carestation CS1. Classified as Incubator, Neonatal (product code FMZ), Class II - Special Controls.

Submitted by Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company (Laurel, US). The FDA issued a Cleared decision on March 17, 2016 after a review of 171 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5400 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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

Submission Details

510(k) Number K152814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2015
Decision Date March 17, 2016
Days to Decision 171 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 128d · This submission: 171d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FMZ Incubator, Neonatal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5400
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.