Cleared Traditional

INFA WARMER I (K102227) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K102227 · Atom Medical Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
165d
Days
Class 2
Risk

K102227 is an FDA 510(k) clearance for the INFA WARMER I. Classified as Warmer, Infant Radiant (product code FMT), Class II - Special Controls.

Submitted by Atom Medical Corporation (Bunkyo-Ku, Tokyo, JP). The FDA issued a Cleared decision on January 21, 2011 after a review of 165 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5130 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Atom Medical Corporation devices

Submission Details

510(k) Number K102227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2010
Decision Date January 21, 2011
Days to Decision 165 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 129d · This submission: 165d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 18
Devices cleared under the same product code (FMT) and FDA review panel - the closest regulatory comparables to K102227.
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K123309 · Ohmeda Medical · Feb 2013
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