Cleared Special

MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY) (K072157) - FDA 510(k) Clearance

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

K072157 · Ohmeda Medical · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
24d
Days
Class 2
Risk

K072157 is an FDA 510(k) clearance for the MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE .... 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 August 27, 2007 after a review of 24 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 K072157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2007
Decision Date August 27, 2007
Days to Decision 24 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
105d faster than avg
Panel avg: 129d · This submission: 24d
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 91
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