Cleared Special

K103527 - AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR PULSEOX

K103527 is an FDA 510(k) clearance for AVIATOR TRANSPORT INCUBATOR WITH MASIMO..., 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 135-day FDA review.

K103527 · International Biomedical, Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
135d
Days
Class 2
Risk

K103527 is an FDA 510(k) clearance for the AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR .... 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 April 15, 2011 after a review of 135 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K103527

510(k) Number K103527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2010
Decision Date April 15, 2011
Days to Decision 135 days
Submission Type Special
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
6d slower than avg
Panel avg: 129d · This submission: 135d
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 21
Devices cleared under the same product code (FPL) and FDA review panel - the closest regulatory comparables to K103527.
185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOX
K103523 · International Biomedical, Ltd. · May 2011
A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NELLOR PULSEOX
K103525 · International Biomedical, Ltd. · May 2011
VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOX
K103524 · International Biomedical, Ltd. · Apr 2011
AVIATOR TRANSPORT INCUBATOR
K081399 · International Biomedical, Ltd. · Jun 2008
V-808 ATOM TRANSCAPSULE
K061071 · Atom Medical, Inc. · Aug 2006
LMT NOMAG IC 3.0
K062052 · Lmt Lammers Medical Technology GmbH · Jul 2006