Cleared Traditional

K040188 - INFINITY GAMMAXL AND SC 6802XL WITH THE SCIO GAS MODULE (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K040188 · Draeger Medical Systems, Inc. · Anesthesiology device
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Apr 2004
Decision
77d
Days
Class 2
Risk

K040188 is an FDA 510(k) clearance for the INFINITY GAMMAXL AND SC 6802XL WITH THE SCIO GAS MODULE. Classified as Analyzer, Gas, Sevoflurane, Gaseous-phase (anesthetic Concentration) (product code NHP), Class II - Special Controls.

Submitted by Draeger Medical Systems, Inc. (Danvers, US). The FDA issued a Cleared decision on April 14, 2004 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1500 - 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 Draeger Medical Systems, Inc. devices

Submission Details

510(k) Number K040188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2004
Decision Date April 14, 2004
Days to Decision 77 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 139d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NHP Analyzer, Gas, Sevoflurane, Gaseous-phase (anesthetic Concentration)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1500
Definition A Sevoflurane Gas Analyzer Is A Device Intended To Measure The Concentration Of Sevoflurane Anesthetic In A Gas Mixture
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.