Cleared Special

K081399 - AVIATOR TRANSPORT INCUBATOR

K081399 is an FDA 510(k) clearance for AVIATOR TRANSPORT INCUBATOR, 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 18-day FDA review.

K081399 · International Biomedical, Ltd. · General Hospital
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Jun 2008
Decision
18d
Days
Class 2
Risk

K081399 is an FDA 510(k) clearance for the 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 June 6, 2008 after a review of 18 days - a notably fast clearance 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. Low regulatory complexity profile. 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 - K081399

510(k) Number K081399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2008
Decision Date June 06, 2008
Days to Decision 18 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 129d · This submission: 18d
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 K081399.
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 WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR PULSEOX
K103527 · International Biomedical, Ltd. · Apr 2011
V-808 ATOM TRANSCAPSULE
K061071 · Atom Medical, Inc. · Aug 2006
LMT NOMAG IC 3.0
K062052 · Lmt Lammers Medical Technology GmbH · Jul 2006
LMT NOMAG IC 1,5
K033565 · Lmt Lammers Medical Technology GmbH · Nov 2003