Cleared Traditional

K040188 - INFINITY GAMMAXL AND SC 6802XL WITH THE SCIO GAS MODULE

K040188 is an FDA 510(k) clearance for INFINITY GAMMAXL AND SC 6802XL WITH THE..., manufactured by Draeger Medical Systems, Inc.. The device is a Class 2 Anesthesiology device with product code NHP cleared through the Traditional 510(k) pathway after a 77-day FDA review.

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

FDA 510(k) Submission Details - K040188

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 140d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NHP Device Classification - Class 2, Special Controls

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.