Cleared Traditional

K112722 - GE DATEX-OHMEDA AVANCE

K112722 is an FDA 510(k) clearance for GE DATEX-OHMEDA AVANCE, manufactured by Datex-Ohmeda, Inc.. The device is a Class 2 Anesthesiology device with product code BSZ cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K112722 · Datex-Ohmeda, Inc. · Anesthesiology device
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Dec 2011
Decision
88d
Days
Class 2
Risk

K112722 is an FDA 510(k) clearance for the GE DATEX-OHMEDA AVANCE. 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 December 16, 2011 after a review of 88 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Datex-Ohmeda, Inc. devices

FDA 510(k) Submission Details - K112722

510(k) Number K112722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2011
Decision Date December 16, 2011
Days to Decision 88 days
Submission Type Traditional
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
52d faster than avg
Panel avg: 140d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 110
Devices cleared under the same product code (BSZ) and FDA review panel - the closest regulatory comparables to K112722.
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