Cleared Traditional

K201628 - Panda iRes Warmer, Giraffe Warmer

K201628 is an FDA 510(k) clearance for Panda iRes Warmer, manufactured by Ge Healthcare. The device is a Class 2 General Hospital device with product code FMT cleared through the Traditional 510(k) pathway after a 241-day FDA review.

K201628 · Ge Healthcare · General Hospital
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Feb 2021
Decision
241d
Days
Class 2
Risk

K201628 is an FDA 510(k) clearance for the Panda iRes Warmer, Giraffe Warmer. Classified as Warmer, Infant Radiant (product code FMT), Class II - Special Controls.

Submitted by Ge Healthcare (Wauwatosa, US). The FDA issued a Cleared decision on February 12, 2021 after a review of 241 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 Ge Healthcare devices

FDA 510(k) Submission Details - K201628

510(k) Number K201628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2020
Decision Date February 12, 2021
Days to Decision 241 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
112d slower than avg
Panel avg: 129d · This submission: 241d
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 K201628.
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