Cleared Traditional

K102227 - INFA WARMER I

K102227 is an FDA 510(k) clearance for INFA WARMER I, manufactured by Atom Medical Corporation. The device is a Class 2 General Hospital device with product code FMT cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K102227 · Atom Medical Corporation · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K102227

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
Combination Product No
PCCP Authorized No
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.

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 72
Devices cleared under the same product code (FMT) and FDA review panel - the closest regulatory comparables to K102227.
GIRAFFE AND PANDA WARMERS
K122267 · Ohmeda Medical, A Division of Datex-Ohmeda, Inc. · Oct 2012
LULLABY TM WARMER
K121625 · Wipro GE Healthcare Private, Ltd. · Sep 2012
SUNFLOWER WARNER
K120937 · Atom Medical Corporation · Jul 2012
GIRAFFE AND PANDA WARMERS
K101804 · Ohmeda Medical, A Division of Datex-Ohmeda, Inc. · Jul 2010
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