Cleared Special

K122267 - GIRAFFE AND PANDA WARMERS

K122267 is an FDA 510(k) clearance for GIRAFFE AND PANDA WARMERS, manufactured by Ohmeda Medical, A Division of Datex-Ohmeda, Inc.. The device is a Class 2 General Hospital device with product code FMT cleared through the Special 510(k) pathway after a 64-day FDA review.

K122267 · Ohmeda Medical, A Division of Datex-Ohmeda, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2012
Decision
64d
Days
Class 2
Risk

K122267 is an FDA 510(k) clearance for the GIRAFFE AND PANDA WARMERS. Classified as Warmer, Infant Radiant (product code FMT), Class II - Special Controls.

Submitted by Ohmeda Medical, A Division of Datex-Ohmeda, Inc. (Laurel, US). The FDA issued a Cleared decision on October 2, 2012 after a review of 64 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5130 - 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.

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

FDA 510(k) Submission Details - K122267

510(k) Number K122267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2012
Decision Date October 02, 2012
Days to Decision 64 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
65d faster than avg
Panel avg: 129d · This submission: 64d
Pathway characteristics
Modification to existing cleared device.

FMT Device Classification - Class 2, Special Controls

Product Code FMT Warmer, Infant Radiant
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5130
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 - FMT Warmer, Infant Radiant

All 38
Devices cleared under the same product code (FMT) and FDA review panel - the closest regulatory comparables to K122267.
NuBorne Infant Warmer
K173516 · International Biomedical · Aug 2018
GIRAFFE AND PANDA WARMERS
K123309 · Ohmeda Medical · Feb 2013
RESUSCITAIRE WITH AUTOBREATH
K120642 · Draeger Medical Systems, Inc. · Nov 2012
MODIFICATION TO: GIRAFFE AND PANDA WARMER
K090697 · Ohmeda Medical · Apr 2009
MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)
K072157 · Ohmeda Medical · Aug 2007
GIRAFFE AND PANDA WARMER
K070377 · Ohmeda Medical · Jul 2007