Cleared Special

K061609 - GE DATEX-OHMEDA AISYS

K061609 is an FDA 510(k) clearance for GE DATEX-OHMEDA AISYS, manufactured by Datex-Ohmeda, Inc.. The device is a Class 2 Anesthesiology device with product code BSZ cleared through the Special 510(k) pathway after a 18-day FDA review.

K061609 · Datex-Ohmeda, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
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Jun 2006
Decision
18d
Days
Class 2
Risk

K061609 is an FDA 510(k) clearance for the GE DATEX-OHMEDA AISYS. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Datex-Ohmeda, Inc. (Madison, US). The FDA issued a Cleared decision on June 27, 2006 after a review of 18 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 Datex-Ohmeda, Inc. devices

FDA 510(k) Submission Details - K061609

510(k) Number K061609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2006
Decision Date June 27, 2006
Days to Decision 18 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
122d faster than avg
Panel avg: 140d · This submission: 18d
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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