Cleared Special

K081941 - NAVIGATOR APPLICATIONS SUITE

K081941 is an FDA 510(k) clearance for NAVIGATOR APPLICATIONS SUITE, manufactured by GE Healthcare Finland Oy. The device is a Class 2 Anesthesiology device with product code BSZ cleared through the Special 510(k) pathway after a 30-day FDA review.

K081941 · GE Healthcare Finland Oy · Anesthesiology device
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Aug 2008
Decision
30d
Days
Class 2
Risk

K081941 is an FDA 510(k) clearance for the NAVIGATOR APPLICATIONS SUITE. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by GE Healthcare Finland Oy (Madison, US). The FDA issued a Cleared decision on August 7, 2008 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5160 - the FDA anesthesiology and respiratory 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 GE Healthcare Finland Oy devices

FDA 510(k) Submission Details - K081941

510(k) Number K081941 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2008
Decision Date August 07, 2008
Days to Decision 30 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 140d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

BSZ Device Classification - Class 2, Special Controls

Product Code BSZ Gas-machine, Anesthesia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5160
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - BSZ Gas-machine, Anesthesia

All 153
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