Cleared Traditional

K121625 - LULLABY TM WARMER

K121625 is an FDA 510(k) clearance for LULLABY TM WARMER, manufactured by Wipro GE Healthcare Private, Ltd.. The device is a Class 2 General Hospital device with product code FMT cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K121625 · Wipro GE Healthcare Private, Ltd. · General Hospital
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Sep 2012
Decision
105d
Days
Class 2
Risk

K121625 is an FDA 510(k) clearance for the LULLABY TM WARMER. Classified as Warmer, Infant Radiant (product code FMT), Class II - Special Controls.

Submitted by Wipro GE Healthcare Private, Ltd. (Laurel, US). The FDA issued a Cleared decision on September 14, 2012 after a review of 105 days - within the typical 510(k) review window.

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 Wipro GE Healthcare Private, Ltd. devices

FDA 510(k) Submission Details - K121625

510(k) Number K121625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2012
Decision Date September 14, 2012
Days to Decision 105 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
24d faster than avg
Panel avg: 129d · This submission: 105d
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 39
Devices cleared under the same product code (FMT) and FDA review panel - the closest regulatory comparables to K121625.
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 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