Cleared Special

K101778 - GIRAFFE INCUBATOR

K101778 is an FDA 510(k) clearance for GIRAFFE INCUBATOR, manufactured by Ohmeda Medical. The device is a Class 2 General Hospital device with product code FMZ cleared through the Special 510(k) pathway after a 26-day FDA review.

K101778 · Ohmeda Medical · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2010
Decision
26d
Days
Class 2
Risk

K101778 is an FDA 510(k) clearance for the GIRAFFE INCUBATOR. Classified as Incubator, Neonatal (product code FMZ), Class II - Special Controls.

Submitted by Ohmeda Medical (Laurel, US). The FDA issued a Cleared decision on July 21, 2010 after a review of 26 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 - K101778

510(k) Number K101778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2010
Decision Date July 21, 2010
Days to Decision 26 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
103d faster than avg
Panel avg: 129d · This submission: 26d
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 K101778.
DUAL INCU I
K102226 · Atom Medical Corporation · Jan 2011
INCU I
K102279 · Atom Medical Corporation · Dec 2010
NEO-SERVO I
K102710 · Atom Medical Corporation · Dec 2010
GIRAFFE OMNIBED
K101788 · Ohmeda Medical · Jul 2010
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
K101778 · GIRAFFE INCUBATOR
Download PDF FDA Summary Ohmeda Medical