Cleared Special

K060461 - V-505 INFA WARMER

K060461 is an FDA 510(k) clearance for V-505 INFA WARMER, manufactured by Atom Medical, Inc.. The device is a Class 2 General Hospital device with product code FMT cleared through the Special 510(k) pathway after a 65-day FDA review.

K060461 · Atom Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
65d
Days
Class 2
Risk

K060461 is an FDA 510(k) clearance for the V-505 INFA WARMER. Classified as Warmer, Infant Radiant (product code FMT), Class II - Special Controls.

Submitted by Atom Medical, Inc. (Tokoyo, Bunkyo-Ku, JP). The FDA issued a Cleared decision on April 28, 2006 after a review of 65 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 Atom Medical, Inc. devices

FDA 510(k) Submission Details - K060461

510(k) Number K060461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2006
Decision Date April 28, 2006
Days to Decision 65 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
64d faster than avg
Panel avg: 129d · This submission: 65d
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 57
Devices cleared under the same product code (FMT) and FDA review panel - the closest regulatory comparables to K060461.
MODIFICATION TO: GIRAFFE AND PANDA WARMER
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