Cleared Special

K071175 - OHMEDA MEDICAL GIRAFFE OMNIBED

K071175 is an FDA 510(k) clearance for OHMEDA MEDICAL GIRAFFE OMNIBED, manufactured by Ge Healthcare. The device is a Class 2 General Hospital device with product code FMZ cleared through the Special 510(k) pathway after a 81-day FDA review.

K071175 · Ge Healthcare · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
81d
Days
Class 2
Risk

K071175 is an FDA 510(k) clearance for the OHMEDA MEDICAL GIRAFFE OMNIBED. Classified as Incubator, Neonatal (product code FMZ), Class II - Special Controls.

Submitted by Ge Healthcare (Laurel, US). The FDA issued a Cleared decision on July 17, 2007 after a review of 81 days - a notably fast clearance 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K071175

510(k) Number K071175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2007
Decision Date July 17, 2007
Days to Decision 81 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 129d · This submission: 81d
Pathway characteristics
Modification to existing cleared device.

FMZ Device Classification - Class 2, Special Controls

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.

Regulatory Peers - FMZ Incubator, Neonatal

All 85
Devices cleared under the same product code (FMZ) and FDA review panel - the closest regulatory comparables to K071175.
TARRY MEDICAL TEMPERATURE PROBES
K071977 · Tarry Medical Products, Inc. · May 2008
MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)
K072512 · Datex-Ohmeda, Inc. · Oct 2007
MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BX
K070291 · Medix I.C.S.A. · Sep 2007
V-2200 INFANT INCUBATOR
K061856 · Atom Medical, Inc. · Sep 2006
VERSALET 7700 CARE CENTER
K053399 · Draeger Medical Infant Care, Inc. · Aug 2006
V-2200 INFANT INCUBATOR
K061280 · Neoforce Group, Inc. · Jun 2006
K071175 · OHMEDA MEDICAL GIRAFFE OMNIBED
Download PDF FDA Summary Ge Healthcare