Cleared Special

K103523 - 185A+ TRANSPORT INCUBATOR WITH MASIMO P...

K103523 is an FDA 510(k) clearance for 185A+ TRANSPORT INCUBATOR WITH MASIMO P..., manufactured by International Biomedical, Ltd.. The device is a Class 2 General Hospital device with product code FPL cleared through the Special 510(k) pathway after a 161-day FDA review.

K103523 · International Biomedical, Ltd. · General Hospital
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May 2011
Decision
161d
Days
Class 2
Risk

K103523 is an FDA 510(k) clearance for the 185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH.... Classified as Incubator, Neonatal Transport (product code FPL), Class II - Special Controls.

Submitted by International Biomedical, Ltd. (Austin, US). The FDA issued a Cleared decision on May 11, 2011 after a review of 161 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5410 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all International Biomedical, Ltd. devices

FDA 510(k) Submission Details - K103523

510(k) Number K103523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2010
Decision Date May 11, 2011
Days to Decision 161 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 129d · This submission: 161d
Pathway characteristics
Modification to existing cleared device.

FPL Device Classification - Class 2, Special Controls

Product Code FPL Incubator, Neonatal Transport
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5410
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 - FPL Incubator, Neonatal Transport

All 7
Devices cleared under the same product code (FPL) and FDA review panel - the closest regulatory comparables to K103523.
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