Cleared Traditional

K070377 - GIRAFFE AND PANDA WARMER

K070377 is an FDA 510(k) clearance for GIRAFFE AND PANDA WARMER, manufactured by Ohmeda Medical. The device is a Class 2 General Hospital device with product code FMT cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K070377 · Ohmeda Medical · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
153d
Days
Class 2
Risk

K070377 is an FDA 510(k) clearance for the GIRAFFE AND PANDA WARMER. 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 July 11, 2007 after a review of 153 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 Ohmeda Medical devices

FDA 510(k) Submission Details - K070377

510(k) Number K070377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2007
Decision Date July 11, 2007
Days to Decision 153 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
24d slower than avg
Panel avg: 129d · This submission: 153d
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 59
Devices cleared under the same product code (FMT) and FDA review panel - the closest regulatory comparables to K070377.
SUNFLOWER WARNER
K120937 · Atom Medical Corporation · Jul 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
INCUWARMER
K971366 · Hill-Rom, Inc. · Jan 1998
SERVO-CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW960, MANUAL CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW970
K972885 · Fisher & Paykel Electronics , Ltd. · Oct 1997
BABYTHERM 8004 BABYTHERM 8010
K971198 · Drager, Inc. · Oct 1997