Cleared Special

K152809 - Giraffe Incubator Carestation CS1 (FDA 510(k) Clearance)

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

K152809 · Ohmeda Medical, A Division of Datex-Ohmeda, Inc. · General Hospital
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Dec 2015
Decision
94d
Days
Class 2
Risk

K152809 is an FDA 510(k) clearance for the Giraffe Incubator Carestation CS1. Classified as Incubator, Neonatal (product code FMZ), Class II - Special Controls.

Submitted by Ohmeda Medical, A Division of Datex-Ohmeda, Inc. (Laurel, US). The FDA issued a Cleared decision on December 31, 2015 after a review of 94 days - within the typical 510(k) review window.

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. devices

Submission Details

510(k) Number K152809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2015
Decision Date December 31, 2015
Days to Decision 94 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
34d faster than avg
Panel avg: 128d · This submission: 94d
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.