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.

View all International Biomedical, Ltd. devices

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
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 7
Devices cleared under the same product code (FPL) and FDA review panel - the closest regulatory comparables to K081399.
NxtGen Infant Transport Incubator
K220742 · International Biomedical · Jul 2022
GLOBE-TROTTER GT5400
K141565 · Draeger Medical Systems, Inc. · Sep 2014
MODEL TI500 ISOLETTE INFANT INCUBATOR
K941106 · Air-Shields, Inc. · Jun 1994
TI-1000 TRANSPORT INCUBATOR
K831028 · Narco Scientific · May 1983
REVISED BATTERY CHARGER
K790689 · Vickers America Medical Corp. · May 1979
TRANSPORT INCUBATOR
K790551 · Narco Air-Shields · Apr 1979