Cleared Special

K090697 - MODIFICATION TO: GIRAFFE AND PANDA WARMER

K090697 is the FDA 510(k) clearance for MODIFICATION TO: GIRAFFE AND PANDA WARMER by Ohmeda Medical. It is a Class 2 General Hospital device (product code FMT) cleared through the Special 510(k) pathway after a 30-day FDA review.

K090697 · Ohmeda Medical · General Hospital
Download Printable Device Report (PDF)
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Apr 2009
Decision
30d
Days
Class 2
Risk

K090697 is an FDA 510(k) clearance for the MODIFICATION TO: GIRAFFE AND PANDA WARMER. Classified as Warmer, Infant Radiant (product code FMT), Class II - Special Controls.

Submitted by Ohmeda Medical (Laurel, US). The FDA issued a Cleared decision on April 16, 2009 after a review of 30 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 devices

Submission Details

510(k) Number K090697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2009
Decision Date April 16, 2009
Days to Decision 30 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
99d faster than avg
Panel avg: 129d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 23
Devices cleared under the same product code (FMT) and FDA review panel - the closest regulatory comparables to K090697.
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 WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)
K072157 · Ohmeda Medical · Aug 2007
GIRAFFE AND PANDA WARMER
K070377 · Ohmeda Medical · Jul 2007
INFANT WARMER SYSTEM
K963058 · Ohmeda Medical · Oct 1996